Gly-sal 10-2 Pads Cloth
FDA Label NDC 51326-039

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 Gly-sal 10-2 Pads (NDC 51326-039). 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 - stop use, otc - keep out of reach of children, directions, 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 acne medication 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.
    • Flammable; keep tightly closed, away from flame and heat.
    • 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

Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.

Warnings

  • For external use only.
  • Keep away from eyes, lips, and mouth.

Otc - Stop Use

  • If irritation develops, discontinue use and consult a doctor.

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

  • Wipe the entire affected area with a moist pad one to three times daily.
  • 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 or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Purified Water, Glycolic Acid, SD Alcohol 40B(13% v/v), Hamamelis Virginiana (Witch Hazel) Water, Ammonium Hydroxide, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Acetone, Disodium EDTA.

Principal Display Panel - 60 Pad Jar Label

REPLENiX®
ACNE SOLUTIONS

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Gly/Sal® 10-2
Pads

Glycolic Acid 10%
Salicylic Acid USP, 2%

60 Pads

Principal Display Panel (60 Pad Jar Label)

Principal Display Panel (60 Pad Jar Label)

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