NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05%- niacinamide 2% / spironolactone 5% / tretinoin 0.05% 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 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05%

Directions for use.

C

Sincerus Florida, LLC adverse reactions.

v

Active, inactive

c

NDC 72934-1153
NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05%
Gel 30 gm.

C

NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05% 
niacinamide 2% / spironolactone 5% / tretinoin 0.05% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1153
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.05 g  in 100 g
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE5 g  in 100 g
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1153-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/03/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/03/2019
Labeler - Sincerus Florida LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida LLC080105003manufacture(72934-1153)

Revised: 5/2019
Document Id: 87ed3aff-1a11-c070-e053-2a95a90af490
Set id: 87ed3aff-1a10-c070-e053-2a95a90af490
Version: 1
Effective Time: 20190502
 
Sincerus Florida LLC