LIDOCAINE 23% / TETRACAINE 7%- lidocaine 23% / tetracaine 7% cream Sincerus Florida, LLCDisclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not beenapproved by FDA. For further information about unapproved drugs, click here.

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LIDOCAINE 23% / TETRACAINE 7%

Directions for use

Sincerus Florida, LLC. Adverse reactions

Active/Inactive

NDC 72934- 2140-2 LIDOCAINE USP 23% / TETRACAINE USP 7%. Ointment 30gm.

LIDOCAINE 23% / TETRACAINE 7% lidocaine 23% / tetracaine 7% cream

Product InformationProduct T ype HUMAN PRESCRIPTION DRUG Ite m Code (Source ) NDC:729 34-2140

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

TETRACAINE (UNII: 0 6 19 F35CGV) (TETRACAINE - UNII:0 6 19 F35CGV) TETRACAINE 7 g in 10 0 g

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 23 g in 10 0 g

Packaging

# Item Code Package Description Marketing StartDate Marketing End Date

1 NDC:729 34-2140 -2

30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio nPro duct 0 5/17/20 19

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

unappro ved drug o ther 0 5/17/20 19

Labeler - Sincerus Florida, LLC (080105003)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Sincerus Flo rida , LLC 0 8 0 10 50 0 3 manufacture(729 34-2140 )

Sincerus Florida, LLC Revised: 6/2020