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
Purpose

Acne medication

Description

Drug Facts

Medication Information

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

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

Purpose

Acne medication

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.

Description

Drug Facts

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.
Active Ingredient

Salicylic Acid USP, 2%

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

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

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

Purpose

Acne medication

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 (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.

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.
Active Ingredient (Active ingredient)

Salicylic Acid USP, 2%

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

Back to search View SPL set listing Open on DailyMed ↗

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