DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%- dapsone 6% / niacinamide 2% / spironolactone 5% 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 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934-1061-2 DAPSONE USP 6% / NIACINAMIDE USP 2% / SPIRONOLACTONE USP 5%. Gel 30gm

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DAPSONE 6% / NIACINAMIDE 2% / SPIRONOLACTONE 5% 
dapsone 6% / niacinamide 2% / spironolactone 5% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE6 g  in 100 g
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE5 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1061-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/11/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1061)

Revised: 5/2019
Document Id: 888b2203-46a0-d599-e053-2995a90a7de1
Set id: 888b2203-469f-d599-e053-2995a90a7de1
Version: 1
Effective Time: 20190510
 
Sincerus Florida, LLC