Replenix Acne Gel
FDA Label NDC 51326-411

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc for the product Replenix Acne (NDC 51326-411). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - when using, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • 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.

Active Ingredient

Benzoyl Peroxide, USP 5%

Purpose

Anti-acne

Uses

  • Topical acne medication.

Otc - When Using

  • When using this product avoid unnecessary sun exposure and use a sunscreen.

Otc - Keep Out Of Reach Of Children

  • 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, 5%
Net wt. 2 oz. (57 g)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Principal Display Panel (57 g Tube Label)

Principal Display Panel (57 g Tube Label)

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