NIACINAMIDE 4% / SPIRONOLACTONE 5%- niacinamide 4% / 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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NIACINAMIDE 4% / 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 72934-1157-2 NIACINAMIDE USP 4% / SPIRONOLACTONE USP 5%. Gel 30gm.

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NIACINAMIDE 4% / SPIRONOLACTONE 5% 
niacinamide 4% / spironolactone 5% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1157
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 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:72934-1157-230 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(72934-1157)

Revised: 5/2019
Document Id: 887acc18-5f42-5c4d-e053-2995a90ae103
Set id: 887acc18-5f41-5c4d-e053-2995a90ae103
Version: 1
Effective Time: 20190509
 
Sincerus Florida, LLC