Label: GLY-SAL 10-2- salicylic acid liquid
- NDC Code(s): 51326-938-01
- Packager: Topiderm, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 13, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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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.
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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
- PRINCIPAL DISPLAY PANEL - 89 ml Bottle Label
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INGREDIENTS AND APPEARANCE
GLY-SAL 10-2
salicylic acid liquidProduct 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)
