Label: BIOARPIL- salicylic acid ointment

  • Category: HUMAN OTC DRUG LABEL

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 December 18, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

  • PURPOSE

    Purpose:

    psoriasis and seborrheic dermatitis

  • 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.

  • INDICATIONS & USAGE

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

  • 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


  • DOSAGE & ADMINISTRATION

    Directions

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

  • 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.
  • PRINCIPAL DISPLAY PANEL


    Product Label

  • INGREDIENTS AND APPEARANCE
    BIOARPIL 
    salicylic acid ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54427-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.8 g  in 140 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BIDENS TRIPARTITA FLOWERING TOP (UNII: 7378E9Z0AL)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HONEY (UNII: Y9H1V576FH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LYSOZYME HYDROCHLORIDE (UNII: 4YRW73H69V)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    RETINOL (UNII: G2SH0XKK91)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54427-001-011 in 1 BOX
    1140 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/01/2012
    Labeler - BIOARPIL USA, INC. (078675445)
    Establishment
    NameAddressID/FEIBusiness Operations
    PRZEDSIEBIORSTWO PRODUKCY JNO HANDLOWE ANTOM366004067manufacture(54427-001)
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