REPLENIX BP ACNE- benzoyl peroxide gel

Replenix BP Acne by

Drug Labeling and Warnings

Replenix BP Acne by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide, USP 10%

Purpose

Anti-acne

Uses

• Topical acne medication.

Warnings

• 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 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, consult a doctor.
• May bleach fabrics.

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

Directions

• 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.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

REPLENiX®
Acne

BP ACNE GEL
10% SPOT
TREATMENT

MEDICAL GRADE INGREDIENTS
Benzoyl Peroxide USP 10%

DERMATOLOGIST
RECOMMENDED

40 YRS

Net 2 oz (57 g)

INGREDIENTS AND APPEARANCE

REPLENIX BP ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-841
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-841-20	57 g in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	05/13/2021

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-841)