DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% gel

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% by

Drug Labeling and Warnings

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% by is a Prescription medication manufactured, distributed, or labeled by Sincerus Florida, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions for use

Sincerus Florida, LLC. Adverse reactions

Active, inactive

NDC:

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

INGREDIENTS AND APPEARANCE

DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% 
dapsone 8.5% / niacinamide 2% / spironolactone 5% gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72934-1064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)	SPIRONOLACTONE	5 g  in 100 g
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)	DAPSONE	8.5 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72934-1064-2	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/10/2019

Labeler - Sincerus Florida, LLC (080105003)

Establishment
Name	Address	ID/FEI	Business Operations
Sincerus Florida, LLC		080105003	manufacture(72934-1064)