Replenix®

Replenix®
SPL v3
SPL
SPL Set ID c12f9005-a549-4447-9beb-df7126f77df1
Route
TOPICAL
Published
Effective Date 2019-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Water Sodium Hydroxymethylglycinate Sodium Lauroyl Sarcosinate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1993-01-22
Description

Drug Facts

Purpose

Anti-acne

Medication Information

Purpose

Anti-acne

Description

Drug Facts

Uses
  • Topical acne medication.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9
  • If irritation develops, discontinue use and consult a doctor.
Section 50567-7
  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
Section 50569-3
  • 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.
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.
Active Ingredient

Benzoyl Peroxide, USP 10%

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

Structured Label Content

Uses
  • Topical acne medication.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
  • If irritation develops, discontinue use and consult a doctor.
Section 50567-7 (50567-7)
  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
Section 50569-3 (50569-3)
  • 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.
Purpose

Anti-acne

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.
Active Ingredient (Active ingredient)

Benzoyl Peroxide, USP 10%

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 57 G Tube Label (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.793879 · Updated: 2026-03-14T23:01:50.647319