Drug Facts

Active ingredient

Benzoyl Peroxide, USP 10%

Purpose

Anti-acne

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, consult a doctor.

Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Cleanse the skin thoroughly before applying.
Apply a thin layer daily, then gradually increase to two or three times daily.
If bothersome drying or peeling occurs, reduce applications.
If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Carbomer, Purified Water, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Stearic Acid.

REPLENiX®
ACNE SOLUTIONS

Acne Gel

Benzoyl Peroxide USP, 10%

Net wt. 2 oz. (57 g)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

REPLENIX ACNE
benzoyl peroxide gel

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51326-412-57	57 g in 1 TUBE; Type 0: Not a Combination Product	01/22/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M006	01/22/1993

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(51326-412)

Name	Address	ID/FEI	Business Operations
Establishment
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-412)