Label: GLY-SAL 2-2 PADS- salicylic acid cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2023

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  • 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

    PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label
  • INGREDIENTS AND APPEARANCE
    GLY-SAL 2-2 PADS 
    salicylic acid cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-923
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-923-0160 in 1 JAR; Type 0: Not a Combination Product12/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00612/16/2019
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-923)
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