DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025%- dapsone 8.5% / niacinamide 2% / tretinoin 0.025% 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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DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025%

Directions for use

h

Sincerus Florida, LLC adverse reactions.

d

Active, inactive

j

NDC 72934-1065-2
DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025%
GEL 30 gm

c

DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% 
dapsone 8.5% / niacinamide 2% / tretinoin 0.025% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE8.5 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1065-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/2019
Labeler - Sincerus Florida LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida LLC080105003manufacture(72934-1065)

Revised: 5/2019
Document Id: 87ed8125-8403-5d53-e053-2995a90a6516
Set id: 87ed8125-8402-5d53-e053-2995a90a6516
Version: 1
Effective Time: 20190502
 
Sincerus Florida LLC