011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025%- 011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% 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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011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025%

Directions for use

Sincerus Florida, LLC adverse reactions

Active, inactive

NDC 72934-1206-2 011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% gel 30 gm

011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025%
011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72934-1206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g in 100 g
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)	SPIRONOLACTONE	5 g in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	0.025 g in 100 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72934-1206-2	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/02/2020

Labeler - Sincerus Florida, LLC (080105003)

Name	Address	ID/FEI	Business Operations
Establishment
Sincerus Florida, LLC		080105003	api manufacture(72934-1206)