DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%- dapsone 8.5% / 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 8.5% / 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 72934-1064-2 DAPSONE USP 8.5% / NIACINAMIDE USP 2% / SPIRONOLACTONE USP 5%. Gel 30gm

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DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% 
dapsone 8.5% / niacinamide 2% / spironolactone 5% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE5 g  in 100 g
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE8.5 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1064-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/10/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-1064)

Revised: 5/2019
Document Id: 887a6d0f-d339-48b9-e053-2a95a90af2a0
Set id: 887a6d0f-d338-48b9-e053-2a95a90af2a0
Version: 1
Effective Time: 20190509
 
Sincerus Florida, LLC