GLY-SAL 2-2 PADS- salicylic acid cloth

Gly-Sal 2-2 Pads by

Drug Labeling and Warnings

Gly-Sal 2-2 Pads by is a Otc medication manufactured, distributed, or labeled by Topiderm, 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.

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.

Warnings

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

• 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.

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.

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

INGREDIENTS AND APPEARANCE

GLY-SAL 2-2 PADS 
salicylic acid cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-923
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg

Inactive Ingredients
Ingredient Name	Strength
AMMONIA (UNII: 5138Q19F1X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCOLIC ACID (UNII: 0WT12SX38S)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
IMIDUREA (UNII: M629807ATL)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-923-01	60 in 1 JAR; Type 0: Not a Combination Product	12/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	12/16/2019

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-923)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-923)