Label: REPLENIX GLY-SAL 10-2 CLEANSER- salicylic acid liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 2, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid USP, 2%

  • Purpose

    Acne medication

  • Uses

    Skin cleanser for the treatment of acne.

  • Warnings

    For external use only

    Keep away from eyes, lips, and mouth.

    Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

    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

    Wet affected area, apply, and rinse well.

    • 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 occurs, reduce application to once a day or every other day.
  • Inactive ingredients

    Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

  • PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

    REPLENiX®
    ACNE SOLUTIONS

    Gly/Sal® 10-2
    Cleanser

    Glycolic Acid 10%
    Salicylic Acid USP, 2%

    Net 6.7 fl. oz. (200 ml)

    Topix Pharmaceuticals, Inc.
    N. Amityville, NY 11701

    PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    REPLENIX GLY-SAL 10-2  CLEANSER
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-928
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-928-01200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00607/26/2021
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-928)
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