Label: GLYCARE ACNE- glycolic acid gel

  • 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 July 5, 2011

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  • ACTIVE INGREDIENT

    Salicylic Acid 1%
  • PURPOSE

    Acne Tratment
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.
  • INDICATIONS & USAGE

    Clears up acne blemishes and helps prevent new acne blemishes.
  • WARNINGS

    For external use only.
  • DOSAGE & ADMINISTRATION

    Directions Cleanse skin thoroughly before applying medication.Cover the entire affected area with a thin layer 1 to 3 times dally. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 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 INGREDIENT

     Water (aqua), sd alcohol 40-b, glycolic acid, ammonium glycolate, hydroxypropyl melhylcellulose.
  • PRINCIPAL DISPLAY PANEL

    Label
    Unit Carton
  • INGREDIENTS AND APPEARANCE
    GLYCARE ACNE 
    glycolic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66078-035-2554 in 1 CASE
    11 in 1 CARTON
    172 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/07/2001
    Labeler - MD Formulation (087008363)
    Registrant - Harmony Labs, Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack
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