gly-sal®

gly-sal®
SPL v2
SPL
SPL Set ID a92a9ffb-5c5b-43a4-b669-04667324920b
Route
topical
Published
Effective Date 2023-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (20 mg)
Inactive Ingredients
ammonia green tea leaf edetate disodium glycolic acid hamamelis virginiana top water imidurea polysorbate 20 water sodium benzoate zinc pidolate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-12-16
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.

Purpose

Acne medication

Directions
  • Wipe the entire affected area with a 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

Ammonium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Imidazolidinyl Urea, Polysorbate 20, Purified Water, Sodium Benzoate.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children
  • 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
  • If swallowed, seek professional assistance or contact a Poison Control Center immediately
  • 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%

Principal Display Panel 60 Pad Jar Label

REPLENiX®

ACNE SOLUTIONS

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Gly/Sal® 2-2

Pads

Glycolic Acid 2%

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.

Purpose

Acne medication

Directions
  • Wipe the entire affected area with a 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

Ammonium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Imidazolidinyl Urea, Polysorbate 20, Purified Water, Sodium Benzoate.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children
  • 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
  • If swallowed, seek professional assistance or contact a Poison Control Center immediately
  • 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 (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® 2-2

Pads

Glycolic Acid 2%

Salicylic Acid USP, 2%

60 Pads

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:28.403213 · Updated: 2026-03-14T23:01:27.375563