Label: BIOARPIL - salicylic acid ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

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  • PURPOSE

    Purpose:

    psoriasis and seborrheic dermatitis

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Uses relieves and helps prevent recurrence of skin itching, irritation, redness, flaking, scaling due to psoriasis and seborrheic dermatitis

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  • WARNINGS

    Warnings

    • For external use only
    • Ask a doctor before use if condition covers a large part of the body
    • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • Stop use and ask a doctor if condition worsens or does not improve after regular use as directed


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  • DOSAGE & ADMINISTRATION

    Directions

    Apply to affected area one to four times daily or as directed by a doctor

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Alpha-Tocopherol Acetate, Bidens Tripartita Flower Top, Calcium Stearate, Cod Liver Oil, Eucalyptus Oil, Honey, Lavender Oil, Lysozyme Hydrochloride, Matricaria Recutita, Mineral Oil, Petrolatum, Retinol.
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  • INGREDIENTS AND APPEARANCE
    BIOARPIL 
    salicylic acid ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54427-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2.8 g  in 140 g
    Inactive Ingredients
    Ingredient Name Strength
    .ALPHA.-TOCOPHEROL ACETATE  
    BIDENS TRIPARTITA FLOWERING TOP  
    CALCIUM STEARATE  
    COD LIVER OIL  
    EUCALYPTUS OIL  
    HONEY  
    LAVENDER OIL  
    LYSOZYME HYDROCHLORIDE  
    MATRICARIA RECUTITA  
    MINERAL OIL  
    PETROLATUM  
    RETINOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54427-001-01 1 in 1 BOX
    1 140 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 07/01/2012
    Labeler - BIOARPIL USA, INC. (078675445)
    Establishment
    Name Address ID/FEI Business Operations
    PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM 366004067 manufacture(54427-001)
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