DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% gel

DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% by

Drug Labeling and Warnings

DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% 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:

72934-1065-2 DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% GEL 30 gm

INGREDIENTS AND APPEARANCE

DAPSONE 8.5% / NIACINAMIDE 2% / TRETINOIN 0.025% 
dapsone 8.5% / niacinamide 2% / tretinoin 0.025% gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72934-1065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302)	DAPSONE	8.5 g  in 100 g
TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)	TRETINOIN	0.025 g  in 100 g
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72934-1065-2	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/03/2019

Labeler - Sincerus Florida LLC (080105003)

Establishment
Name	Address	ID/FEI	Business Operations
Sincerus Florida LLC		080105003	manufacture(72934-1065)