REPLENIX ACNE- benzoyl peroxide gel

Replenix Acne by

Drug Labeling and Warnings

Replenix Acne by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals, 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 Tube Label

REPLENiX®
ACNE SOLUTIONS

Acne Gel

Benzoyl Peroxide USP, 10%

Net wt. 2 oz. (57 g)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

INGREDIENTS AND APPEARANCE

REPLENIX ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-412
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
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
Sodium Hydroxymethylglycinate (UNII: DIG6BWZ9XT)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
Stearic Acid (UNII: 4ELV7Z65AP)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/22/1993

Labeler - Topiderm, Inc. (049121643)