Replenix Gly-sal 10-2 Liquid
FDA Label NDC 51326-928

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 Gly-sal 10-2 (NDC 51326-928). 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, warnings, 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

Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Active Ingredient

Salicylic Acid USP, 2%

Purpose

Acne medication

Uses

Skin cleanser for the treatment of acne.

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

Directions

Wet affected area, apply, and rinse well.

  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician
  • If bothersome dryness occurs, reduce application to once a day or every other day.

Inactive Ingredients

Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

Principal Display Panel - 200 Ml Bottle Label

REPLENiX®
ACNE SOLUTIONS

Gly/Sal® 10-2
Cleanser

Glycolic Acid 10%
Salicylic Acid USP, 2%

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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