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SALICYLIC ACID (CVS)

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LIQUID 120 mL in 1 BOTTLE (59779-078-08) Label Information

Complete SALICYLIC ACID Information

  • ACTIVE INGREDIENT

    Active ingredient                      Purpose
    Salicylic Acid
    (0.5%)....................................Acne Medication

  • PURPOSE


    Active ingredient                 Purpose
    Salicylic Acid
    (0.5%)..............................Acne Medication
    ______________________________________

    Use for the management of acne
  • KEEP OUT OF REACH OF CHILDREN


    _______________________________

    Keep out of reach of children. In
    case of accidental ingestion, get
    medical help or contact a Poison
    Control Center right away.

  • INDICATIONS & USAGE

    Use for the management of acne
    _______________________________

    Directions
    - Cleanse skin thoroughly before
    applying medication
    - cover the entire affected area with
    a thin layer one to two times daily
    - because excessive drying of the
    skin may occur, start with one
    application daily, then gradually
    increase to two or 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
  • WARNINGS

    Warnings
    For external use only.

    Using other topical acne
    medications 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.
    ______________________________

    When using this product avoid
    contact with eyes. If contact occurs,
    immediately flush with water.
    _______________________________

    Keep out of reach of children. In
    case of accidental ingestion, get
    medical help or contact a Poison
    Control Center right away.

  • DOSAGE & ADMINISTRATION


    Directions
    - Cleanse skin thoroughly before
    applying medication
    - cover the entire affected area with
    a thin layer one to two times daily
    - because excessive drying of the
    skin may occur, start with one
    application daily, then gradually
    increase to two or 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

  • INACTIVE INGREDIENT

    Inactive Ingredients Water,
    Dicaprylyl Ether, Glycerin,
    Dimethicone, Neopentyl Glycol
    Diethylhexanonate, Neopentyl Glycol
    Diisostearate, Aluminum Starch,
    Octenylsuccinate, Methyl Gluceth
    -20, Diacetyl Phosphate, Ceteth-10
    Phosphate, Cetearyl Alcohol,
    Menthyl Lactate, Steareth-20,
    Steareth-2, Fragrance, Xanthan
    Gum, Lecithin, Disodium EDTA,
    Sodium Hydroxide, Magnesium
    Aluminum Silicate, BHT
  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-078
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MENTHYL LACTATE (UNII: 2BF9E65L7I)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-078-08 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 05/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    Name Address ID/FEI Business Operations
    Pharma Pac, LLC 140807475 manufacture