Label: SALICYLIC GEL- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53634-153-01 - Packager: Malin and Goetz Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 23, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase totwo oe three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
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INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua/Eau, Alcohol Denat., Glycerin, Lactic Acid, Hydroxyethylcellulose, Sodium Hydroxide, Centella Asiatica Extract, Niacinamide, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Disodium EDTA, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Artemisia Absinthum Oil, Mentha Viridis (Spearmint) Leaf Oil, Tagetes Minuta Flower Oil, Achillea Millefolium Flower Extract.
- OTHER SAFETY INFORMATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALICYLIC GEL
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-153 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength SALIX ALBA BARK (UNII: 205MXS71H7) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) XANTHAN GUM (UNII: TTV12P4NEE) PEPPERMINT OIL (UNII: AV092KU4JH) TAGETES MINUTA FLOWER OIL (UNII: 1T0ZMU8M8B) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) LACTIC ACID (UNII: 33X04XA5AT) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) SODIUM HYDROXIDE (UNII: 55X04QC32I) NIACINAMIDE (UNII: 25X51I8RD4) WORMWOOD OIL (UNII: 01756N87N8) SPEARMINT OIL (UNII: C3M81465G5) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-153-01 15 mL in 1 TUBE; Type 0: Not a Combination Product 11/23/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 11/23/2022 Labeler - Malin and Goetz Inc (138615930)
