Gly-sal®

Gly-sal®
SPL v4
SPL
SPL Set ID b39e845d-4c40-4f9e-9cb5-a8386f326652
Route
TOPICAL
Published
Effective Date 2019-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 g)
Inactive Ingredients
Water Glycolic Acid Alcohol Hamamelis Virginiana Top Water Ammonia Polysorbate 20 Sodium Benzoate Imidurea Acetone Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-07-28
Description

Drug Facts

Purpose

Acne medication

Medication Information

Purpose

Acne medication

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9
  • If irritation develops, discontinue use and consult a doctor.
Warnings
  • For external use only.
  • Keep away from eyes, lips, and mouth.
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.
Active Ingredient

Salicylic Acid USP, 2%

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
  • If irritation develops, discontinue use and consult a doctor.
Purpose

Acne medication

Warnings
  • For external use only.
  • Keep away from eyes, lips, and mouth.
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.
Active Ingredient (Active ingredient)

Salicylic Acid USP, 2%

Inactive Ingredients (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 (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:17.324268 · Updated: 2026-03-14T23:01:42.949822