Drug Facts

Active ingredients

Benzoyl Peroxide USP, 5%

Purpose

Acne treatment

BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.

When using this product avoid unnecessary sun exposure and use a sunscreen.
For external use only.
Keep away from eyes, lips, and mouth.
If irritation or sensitivity develops, discontinue use and consult a doctor.
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, only one medication should be used unless directed by a doctor.
May bleach fabrics.

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

Shake well. Wet affected area, wash, and rinse well.
Use once or twice daily or as directed by a physician.
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, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

REPLENiX®
ACNE SOLUTIONS

Acne Wash

Benzoyl Peroxide USP, 5%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

REPLENIX ACNE SOLUTION BENZOYL PEROXIDE WASH
benzoyl peroxide liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51326-111-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M006	11/01/2017

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(51326-111)

Name	Address	ID/FEI	Business Operations
Establishment
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-111)