011504 DAPSONE 8.5% / NIACINAMIDE 4%- 011504 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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011504 DAPSONE 8.5% / NIACINAMIDE 4%

Directions for use

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Sincerus Florida, LLC adverse reactions

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Active, inactive

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NDC 72934-1212-2 011504 DAPSONE 8.5% / NIACINAMIDE 4% gel 30 gm

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011504 DAPSONE 8.5% / NIACINAMIDE 4% 
011504 dapsone 8.5% / niacinamide 4% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1212
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:72934-1212-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/02/2020
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1212)

Revised: 7/2020
Document Id: a97aeb21-4efd-3d91-e053-2995a90a2298
Set id: a97aeb21-4efc-3d91-e053-2995a90a2298
Version: 1
Effective Time: 20200702
 
Sincerus Florida, LLC