Gly-sal®

Gly-sal®
SPL v5
SPL
SPL Set ID e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8
Route
TOPICAL
Published
Effective Date 2019-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-02-27

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

Principal Display Panel 60 Pad Jar Label

REPLENiX®

ACNE SOLUTIONS

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Gly/Sal® 5-2

Pads

Glycolic Acid 5%

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, SD Alcohol 40B (13% v/v), Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Ammonium Hydroxide, 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® 5-2

Pads

Glycolic Acid 5%

Salicylic Acid USP, 2%

60 Pads


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)