GLY-SAL 10-2- salicylic acid liquid

Gly-Sal 10-2 by

Drug Labeling and Warnings

Gly-Sal 10-2 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 2%

Purpose

Acne medication

Uses

For the treatment of acne of the body, with the skin enhancement properties of glycolic acid

Warnings

• For external use only.
• Direct spray away from face, especially 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

• Spray the entire affected area of the body 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

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

PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label

COMPLIMENTS OF

TOPIX
PHARMACEUTICALS, INC

Gly/Sal 10-2
Spray

Glycolic Acid 10%
Salicylic Acid USP, 2%

Net 3 fl. oz. (89 ml)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

GLY-SAL 10-2 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-938
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  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCOLIC ACID (UNII: 0WT12SX38S)	100 mg  in 1 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM C12-15 ALKETH-15 SULFONATE (UNII: 353VA59XH8)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-938-01	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	06/10/2019

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-938)