FREE BONUS offer! Therapy Guide · 12/31/2013 · lus 20 years of PreviDent® leadership in Rx...

YOUR PARTNER IN ORAL HEALTH2013

YOUR PARTNER IN ORAL HEALTH

or call 1-800-2COLGATE to speak to your Oral Care Consultant today

©2013 Colgate Oral Pharmaceuticals, a subsidiary of Colgate-Palmolive Company, New York, NY 10022, USA 03/2013 SO407171www.colgateprofessional.com

FLUORIDETherapy Guide

YOUR PARTNER IN ORAL HEALTH YOUR PARTNER IN ORAL HEALTH

FREE BONUS offer!

Eligibility: New Offices that have not purchased PreviDent® home fluoridesin latest 12 months.

If you buy 48 units of PreviDent® home fluorides, you can receive:

543-0159Raspberry

2- PreviDent® Varnish boxes (50ct each) Offer expires 12/31/2013

YOUR PARTNER IN ORAL HEALTHTake-Home Fluoride Therapy

Take-home fluoride therapy ............ 3

In-office fluoride ............................... 9

Catalog & plan pricing .................. 11

Table of Contents

2 | To Order: 1.800.372.4346 www.colgateprofessional.com | 3

Plus Over 4X better remineralization†1

Plus 86% greater enamel fluoride uptake†2

Plus FluoriGard™‡ Technology

Plus 20 years of PreviDent® leadership in Rx fluorides

our most advanced FormuLa For

UNSURPASSEDREMINERALIZATION*1

1.1% Sodium Fluoride Anti-caries Toothpaste (Rx Only)

PreviDent® 5000 BOOsTER Plus

YOUR PARTNER IN ORAL HEALTH

Contains tricalcium phosphate

Contains tricalcium phosphate

Important Safety Information: PreviDent® 5000 Booster Plus (1.1% Sodium Fluoride) is a dental caries preventative toothpaste for adults and pediatric patients 6 years of age and older.The product is for once daily, topical use. It is not to be swallowed. Allergic reactions and idiosyncrasies have been rarely reported. See page 12 for brief summary of risk information.

* Comparison vs ClinPro™ 5000 toothpaste and MI Paste Plus™ topical creme. † Comparison vs PreviDent® 5000 Booster. ‡ Optimized fluoride delivery system. 1. Data on file; Colgate-Palmolive, 2012. In vitro pH cycling model after 10 and 20 days. 2. Data on file; Colgate-Palmolive, 2012. In vitro standard method for enamel fluoride uptake.

Close picture box here for non bleed itemPlus FluoriGard™ ‡ Technology

An optimized fluoride delivery system that produces a temporary shift in the pH, resulting in an 86% improvement in fluoride uptake.†2

Plus 20 years of PreviDent® leadership in Rx FluoridesAssess often to identify those at risk of caries and prescribe Colgate® PreviDent® 5000 Booster PLUS.

Colgate® PreviDent® 5000 Booster Plus (Rx Only) 1.1 Sodium Fluoride Prescription-strength Toothpaste

3.4 fl. oz. (100 mL) Spearmint

Plus unsurpassed Remineralization

FPO

150

100

50

-50

0

200

250

Fluoride-Free MI Paste Plus™ ClinPro™ 5000 ImprovedPreviDent® 5000

Booster PLUS

10 days

20 days

% C

hang

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Sur

face

Mic

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rdne

ss

Remineralization after 10 and 20 days2

unsurPassed remIneraLIZatIon AFTER 20 DAYS*

1

Better remIneraLIZatIon AFTER 10 DAYS§1

Polished enamel specimens were acid challenged to create lesions, then evaluated for baseline surface microhardness. Specimens were then exposed to an in vitro pH-cycling model consisting of periods of acid challenge (favoring demineralization; 4 hours daily), fluoride exposure (via toothpaste slurry exposure; 1 minute, 4 times daily), and artificial saliva (favoring remineralization; 20 hours each day) for 20 days. Surface microhardness measurements were repeated at day 10 and day 20 for comparison to baseline, and reported as percent change in surface microhardness after 10 or 20 days of pH cycling.

PreviDent® 5000 BOOsTER Plus

3.4 fl. oz. (100 mL) Fruitastic™

references: 1. Data on file; Colgate-Palmolive, 2012. In vitro pH cycling model after 10 and 20 days. 2. Data on file; Colgate-Palmolive, 2012. In vitro standard method for enamel fluoride uptake.

§ Statistically better when compared to ClinPro™ 5000, MI Paste Plus™ topical creme, and PreviDent® 5000 Booster.

ClinPro™ 5000 is a registered trademark of 3M Espe. MI Paste Plus™ topical creme is a registered trademark of GC America, Inc.4 | To Order: 1.800.372.4346 www.colgateprofessional.com | 5

Colgate® PreviDent® 5000 Sensitive

1.1% sodium fluoride, 5,000 ppm fluoride, Prescription strength fluoride toothpaste with 5% potassium nitrate to provide sensitivity relief in a unique liquid gel formula.

Colgate®PreviDent® 5000 Enamel Protect 1.1% sodium fluoride, 5,000 ppm fluoride, Prescription strength fluoride toothpaste with 5% potassium nitrate formulated to help strengthen tooth enamel and help with sensitivity relief.

1. Data on file; Colgate-Palmolive, Horchos M. May 2007.

• Clinically proven fluoride technology to significantly remineralize root caries by 38% in less than 3 months1

• Liquid gel formula enables faster fluoride dispersion than paste-form Rx toothpaste2

• One-step fluoride treatment to help improve patient compliance

• Ideal therapy for patients with high caries risk, crown & bridge work, and orthodontic decalcification

• Mild cleaning system with low level abrasion

1. Baysan A., et al, Reversal of primary root caries using dentifrices containing 5,000 ppm and 1,100 ppm fluoride. Caries Res 2001:35:41-46. 2. Joziak MT, et al. Comparison of enamel fluoride uptake and fluoride release from liquid and paste dentifrice. J Dent Res. 2003; 82 (Sp Issue). Abstract 1355.

Colgate® PreviDent® 5000 Dry Mouth

1.1% sodium fluoride, 5,000 ppm fluoride Soothing mint flavor formulated to appeal to dry mouth sufferers 1.

For Specific Patient Needs

Not all patients are the same... Choose the right PreviDent® 5000 for your patient!

pp

m fl

uori

de

rele

ase

4500

4000

3500

3000

2500

2000

1500

1000

500

0

Time (Seconds)

0 5 10 15 20 25 30

+26%

5000 ppm Toothpaste

PreviDent® 5000 Liquid Gel Dentifrice

Fluoride dispersion

®

®

®

®


YOUR PARTNER IN ORAL HEALTHIn-Office Fluoride Therapy

PreviDent® 5000 Plus®

1.1% sodium fluoride Prescription strength fluoride toothpaste shown to significantly remineralize root caries and strengthen teeth1.

PreviDent® Gel

1.1% sodium fluoride An effective second fluoride treatment after brushing with an ordinary fluoride toothpaste2.

Gel-Kam® Gel

0.4% stannous fluoride An effective second fluoride treatment after brushing with a fluoride toothpaste to remineralize enamel3 & provide sensitivity relief.

PreviDent® Rinse

0.2% sodium fluoride Up to 55% caries reduction with weekly use4.

Take-home fluoride therapy


1. Baysan A et al. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Caries Res. 2001; 35:41-46. 2. DePaola PF. “Caries in our aging population: what are we learning.” In: Bowen WH & Tabak LS (eds.). Cariology for the nineties. Rochester, University of Rochester Press, 1993, pp. 25-35. 3. Boyd RL. Long-term evaluation of SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients. Int Dent J. 1994; 44:119-130. 4. Driscoll et al. Caries-preventive effects of daily and weekly fluoride mouthrinsing in a fluoridated community: final results after 30 months. JADA. 1982; 105:1010-1013.

PreviDent® Varnish

5% sodium fluoride

In-office fluoride therapy

www.colgateprofessional.com | 11

Patient Condition• Dentin hypersensitivity • Post scaling / root planing• Post periodontal surgery • Root exposure• Medium to high caries risk*

Mode of Action Deposition of significant amounts of calcium fluoride that inhibit dentin fluid flow and provide a reservoir of fluoride ions

Dental Professional and Patient Benefits

• Ready-to-use unit dose treatment• Highest fluoride concentration available (22,600 ppm F-) as compared to non-varnish fluorides• Provides high concentration of fluoride at the enamel and exposed dentin surface• Dries to Natural Enamel Color• Contains xylitol

*Use of fluoride varnish for caries prevention has been endorsed by the ADA Council of Scientific Affairs. Although FDA has cleared fluoride varnish to be used as cavity varnishes/liners and for the treatment of hypersensitive teeth, caries prevention is an “off-label” use because FDA has not cleared it for this purpose. (ADA Council of Scientific Affairs. J Am Dent Assoc 2006).

10 | To Order: 1.800.372.4346

Take-Home Fluoride

In-Office Fluoride

Catalog & plan pricing

Product Item # Catalog Plan

Unit Minimums 1 12 48 96 144 288 576

Booster Plus Spearmint 543-0080-D1

Booster Plus Fruitastic™ 543-0079-D1

Sensitive 543-3243-D1

Dry Mouth 543-2898-D1 $8.49 $7.99 $7.49 $6.99 $6.49 $5.99 $5.49

Enamel Protect 543-0025-D1

5000 Plus - Spearmint 543-5917-D1

5000 Plus - Fruitastic™ 543-9752-D1

Gel - Fresh Mint 543-0562-D1 $6.29 $6.19 $5.99 $5.66 $5.03

Gel - Very Berry 543-8854-D1

Rinse 543-2879-D1 $8.69 $8.39 $7.89 $7.30 $6.56

Gel-Kam® Gel - Mint 543-6347-D1 $5.79 $5.59 $5.29 $4.92 $4.61

Gel-Kam® Gel - Fruit & Berry 543-6567-D1

Product Item # Catalog Plan

Box Minimums 1 3 5 25

Varnish - Raspberry 50 dose 543-0159-D1 $87.99 $76.99 $65.99 $59.39

Varnish - Mint 50 dose 543-0006-D1

Varnish - Raspberry 150 dose 543-3558-D1 $199.00

Varnish - Mint 150 dose 543-2479-D1

®

®

PRESCRIPTION STRENGTH TOOTHPASTE FOR SENSITIVE TEETH

1.1% Sodium Fluoride5% Potassium Nitrate

SENSITIVE

DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients: Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied

onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion. (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.

Rev. 11/08

®

®



ENAMEL PROTECT

DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients: Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental

professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)


WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5


OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Enamel Protect contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1

minute, expectorate, and rinse mouth thoroughly. 2. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a

dentist or physician.

Rev. 12/10

®

®

1.1% Sodium Fluoride

PRESCRIPTION STRENGTH TOOTHPASTE

DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

Active Ingredient: Sodium fluoride 1.1% (w/w)

INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular

toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)


WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of PreviDent® 5000 BoosterPlus in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5


OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 BoosterPlus contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 605 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 BoosterPlus to a toothbrush. Brush teeth thoroughly once daily for two minutes,

preferably at bedtime, in place of your regular toothpaste.2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.

Rev. 07/12


®

®

1.1% Sodium Fluoride*Formulated for Dry Mouth Sufferers

DRY MOUTH


DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride for use as a dental caries preventative in adults and pediatric patients.

Active Ingredient: Sodium fluoride1.1% (w/w)

INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking

water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)


WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of PreviDent® 5000 Dry Mouth in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5


OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Dry Mouth contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 608 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes,

preferably at bedtime, in place of your regular toothpaste.2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16 years of age, expectorate after use and rinse mouth

thoroughly.

Rev. 11/08

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DRY MOUTH


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Acidulated Phosphate Fluoride Solution0.2% Neutral Sodium Fluoride

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SENSITIVE1.1% Sodium Fluoride

Non-abrasive formula is gentle on teeth and gums

0.4% Stable Stannous Fluoride

PREVENTATIVE TRE ATMENT GEL

0.63% Stannous Fluoride ConcentrateORAL CARE RINSE

5% Sodium Fluoride 5% Sodium Fluoride

V A R N I S H

DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries preventive in adults and pediatric patients.

ACTIVE INGREDIENT: Sodium Fluoride 1.1% (w/w).

INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Plus® brand of 1.1% sodium fluoride in a squeeze-tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)


WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox,

and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of PreviDent® 5000 Plus® in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/w) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5


OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Plus® contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Plus® to a toothbrush. Brush thoroughly once daily for two

minutes, preferably at bedtime. 2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse

mouth thoroughly.

REV 05/03

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DRY MOUTH


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V A R N I S H

DESCRIPTION: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice.

ACTIVE INGREDIENTS: Sodium Fluoride (NaF) 1.1% (w/v).

INDICATIONS AND USAGE: A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional.


WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of PreviDent® Brush-On Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


Overdosage: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® Gel contains approximately 2 mg fluoride. A 0.8 oz. tube contains approximately 104 mg fluoride. A 2 oz. tube contains approximately 266 mg fluoride.

DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional: 1. After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with

a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime.2. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and

rinse mouth thoroughly.

REV 05/03

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DRY MOUTH


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V A R N I S H

DESCRIPTION: PreviDent® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral, aqueous solution containing 6% alcohol.

Active Ingredient: Sodium Fluoride 0.2% (w/v).

INDICATIONS AND USAGE: A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in pediatric patients. PreviDent® Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

CONTRAINDIACTIONS: Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

WARNINGS: Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING

PRECAUTIONS: General: Not for systemic treatment. DO NOT SWALLOW. Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenesis was found in mice or female rats treated with fluoride at doses ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In another study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems but has been associated with chromosome aberrations in cultured human and rodent cells at doses much higher than expected human exposures. Some in vivo report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect litter size or fetal weight and did not increase frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Pediatric Use: The use of PreviDent® Rinse as a weekly caries preventive in pediatric patients aged 6 to 16 years is supported by adequate and well-controlled clinical studies in students aged 6 to 12 years.1-3 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections. Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS: In patients with mucositis, gingival tissues may be hypersensitive to flavor or alcohol present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.

OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (10 mL or two teaspoonfuls) of PreviDent® Rinse contains approximately 9 mg fluoride. One 16 fl. oz. bottle contains approximately 429 mg fluoride.

DOSAGE AND ADMINISTRATION: For caries — Adults and pediatric patients over age 6 years, 2 teaspoonfuls (10 mL). Once a week, preferably at bedtime after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.

Rev. 02/09

5% Sodium Fluoride

DESCRIPTION: PreviDent 5% Sodium Fluoride Varnish contains 22,600 ppm fluoride. It has a strong desensitizing action when applied to dental surfaces, treating hypersensitivity quickly and easily. This product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent® Varnish will leave a thin film on the teeth after application.

COMPOSITION: 1 mL of this suspension contains 50 mg sodium fluoride, equivalent to 22.6 mg fluoride ion, in an alcoholic solution of natural resins.

INDICATIONS: PreviDent® Varnish is a topical fluoride for the treatment of dentinal and post operative sensitivity.

DOSAGE: To be administered by the dental professional for the treatment of dentin hypersensitivity. The fluoride content in this product is dosed in such a way that neither acute nor chronic side effects are to be expected if applied according to the instructions.

DIRECTIONS FOR USE: PlEASE ObSERVE WhEN TREATING hyPERSENSITIVE TEETh 1. Wash and dry tooth surface. 2. Mix well prior to application. 3. Apply product with supplied brush in the conventional manner. 4. Thin excess varnish on the tooth’s surface until the varnish surface is dry. 5. Covers even moist teeth with a coating of varnish film for several hours which occludes the openings of the dental tubules. 6. Hardens on contact with saliva so the patient may leave immediately after application of the product. 7. It is recommended that the patient be instructed to eat only soft foods for 2 hours after treatment.

CONTRAINDICATIONS: Ulcerative gingivitis and stomatitis

INTERACTIONS: When PreviDent® Varnish is applied, other fluoride preparations such as fluoride gels should not be administered during the same day. The routine use of fluoride tablets should be interrupted for several days after treatment.

ADVERSE REACTIONS: Edematous swellings have been reported only in rare instances in some fluoride varnish products, especially after application to extensive surfaces. Dyspnea, although extremely rare, has occurred in asthmatic children. Nausea has been reported when extensive applications have been made. If required, varnish film can be removed with a thorough brushing. Store in a cool, dry place.

Rev. 12/08


FREE BONUS offer! Therapy Guide · 12/31/2013 · lus 20 years of PreviDent® leadership in Rx...

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Transcript of FREE BONUS offer! Therapy Guide · 12/31/2013 · lus 20 years of PreviDent® leadership in Rx...