DAPSONE 8.5% / NIACINAMIDE 4%- dapsone 8.5% / 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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DAPSONE 8.5% / NIACINAMIDE 4%

Directions for use

f

Sincerus Florida, LLC adverse reactions.

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Active, inactive

d

NDC 72934-1066-2
DAPSONE 8.5 / NIACINAMIDE 4
Gel 30gm

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DAPSONE 8.5% / NIACINAMIDE 4% 
dapsone 8.5% / niacinamide 4% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE8.5 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:72934-1066-230 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(72934-1066)

Revised: 4/2019
Document Id: 8738b667-e55c-5543-e053-2991aa0a5530
Set id: 8738b667-e55b-5543-e053-2991aa0a5530
Version: 1
Effective Time: 20190423
 
Sincerus Florida, LLC