GLY-SAL 10-2 PADS- salicylic acid cloth

Gly-Sal 10-2 Pads by

Drug Labeling and Warnings

Gly-Sal 10-2 Pads by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid USP, 2%

Purpose

Acne medication

Uses

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

Warnings

• For external use only.
• Keep away from 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.

• 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

• 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.

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

INGREDIENTS AND APPEARANCE

GLY-SAL 10-2 PADS 
salicylic acid cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.02 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycolic Acid (UNII: 0WT12SX38S)
Alcohol (UNII: 3K9958V90M)
Hamamelis Virginiana Top Water (UNII: NT00Y05A2V)
Ammonia (UNII: 5138Q19F1X)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
Imidurea (UNII: M629807ATL)
Acetone (UNII: 1364PS73AF)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-039-60	60 in 1 JAR; Type 0: Not a Combination Product	07/28/2000

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/28/2000

Labeler - Topiderm, Inc. (049121643)