Replenix Acne 10% Wash Paraben Free With Aloe Liquid
FDA Label NDC 51326-113

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 10% Wash Paraben Free With Aloe (NDC 51326-113). 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 ingredients, purpose, uses, otc - keep out of reach of children, directions, inactive ingredients, principal display panel - 200 ml bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

  • 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.

Active Ingredients

Benzoyl Peroxide USP, 10%

Purpose

Acne treatment

Uses

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

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

  • 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.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Carbomer, Disodium EDTA, Fragrance, Maltodextrin, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.

Principal Display Panel - 200 Ml Bottle Label

REPLENiX®
ACNE SOLUTIONS

Acne Wash
with Aloe Vera

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Principal Display Panel (200 ml Bottle Label)

Principal Display Panel (200 ml Bottle Label)

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