ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%- adapalene 0.3% / 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 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4%

Directions or use

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Sincerus Florida, LLC adverse reactions.

g

Active, inactive

123

NDC 72934-1005-2
ADAPALENE 0.3 / BENZOYL PEROXIDE 2.5 / NIACINAMIDE 4
gel 30gm

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ADAPALENE 0.3% / BENZOYL PEROXIDE 2.5% / NIACINAMIDE 4% 
adapalene 0.3% / benzoyl peroxide 2.5% / niacinamide 4% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 100 g
ADAPALENE (UNII: 1L4806J2QF) (ADAPALENE - UNII:1L4806J2QF) ADAPALENE0.3 g  in 100 g
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1005-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1005)

Revised: 6/2020
Document Id: a731513c-c772-31e3-e053-2a95a90aba86
Set id: 87391cb8-def0-a107-e053-2991aa0a561b
Version: 2
Effective Time: 20200603
 
Sincerus Florida, LLC