Gly-sal 10-2 Liquid
FDA Label NDC 51326-938

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 (NDC 51326-938). 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

Active Ingredient

Salicylic Acid 2%

Purpose

Acne medication

Uses

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Warnings

  • For external use only.
  • Direct spray away from face, especially eyes, lips and mouth.
  • If irritation develops, discontinue use and consult a doctor.
  • 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.

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.
  • 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.

Directions

  • Spray the entire affected area of the body 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

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

Principal Display Panel - 89 Ml Bottle Label

COMPLIMENTS OF

TOPIX
PHARMACEUTICALS, INC

Gly/Sal 10-2
Spray

Glycolic Acid 10%
Salicylic Acid USP, 2%

Net 3 fl. oz. (89 ml)

Available
Custom Branded
800.445.2595
[email protected]

Principal Display Panel (89 ml Bottle Label)

Principal Display Panel (89 ml Bottle Label)

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