011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%- 011054 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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011054 NIACINAMIDE 4% / SPIRONOLACTONE 5%

Directions for use

a

Sincerus Florida, LLC adverse reactions

AD

Active, inactive

s

NDC 72934-1205-2 011054 NIACINAMIDE 4% / SPIRONOLACTONE 5% gel 30 gm

s

011054 NIACINAMIDE 4% / SPIRONOLACTONE 5% 
011054 niacinamide 4% / spironolactone 5% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1205
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:72934-1205-230 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(72934-1205)

Revised: 7/2020
Document Id: a97c130d-1427-824b-e053-2995a90ad22f
Set id: a97c130d-1426-824b-e053-2995a90ad22f
Version: 1
Effective Time: 20200702
 
Sincerus Florida, LLC