ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%- adapalene 0.1% / benzoyl peroxide 2.5% / niacinamide 4% gel 
Sincerus Florida, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%

Directions for use

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Sincerus Florda, LLC. Adverse reactions

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Active/Inactives

123

NDC 72934-1003-2 ADAPALENE USP 0.1% / BENZOYL PEROXIDE USP 2.5% / NIACINAMIDE USP 4%
Gel 30gm

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ADAPALENE 0.1% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4% 
adapalene 0.1% / benzoyl peroxide 2.5% / niacinamide 4% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE0.1 g  in 100 g
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1003-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/10/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1003)

Revised: 6/2020
Document Id: a731072c-256d-aaed-e053-2a95a90ad13c
Set id: 887a6d0f-d351-48b9-e053-2a95a90af2a0
Version: 2
Effective Time: 20200603
 
Sincerus Florida, LLC