Label: DIVAS WINTERGREEN- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Isopropyl Alcohol 50%

  • PURPOSE

    Purpose
    First aid antiseptic
  • INDICATIONS & USAGE

    Uses
    First aid to help prevent risk of infection in  •scrapes •burns •minor cuts
  • WARNINGS

    Warnings
    For external use only  •Flammable Keep away from fire and flames
  • ASK DOCTOR

    Consult a doctor before use if you have
    animal bites or serious burns, deep or punctured wounds
  • WHEN USING

    When using this product
    •do not let it get into your eyes
    •do not apply over large areas of the body
    •do not use longer than a week unless directed by the doctor
    •do not use other than as directed
  • STOP USE

    Stop use and consult a doctor  if condition persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

    Enter section text here

  • DOSAGE & ADMINISTRATION

    Directions
    •clean affected area
    •apply a small amount of this product on the affected area 1-3 times a day
    •may be covered with a sterile bandage but let dry before using bandage
  • SPL UNCLASSIFIED SECTION

    Other information
    Store at controlled room temperature
    Not intended as substitute for grain or ethyl alcohol
    Will produce serious gastric disturbance if taken internally
  • INACTIVE INGREDIENT

    Inactive ingredients
    Green 3, yellow 5, methyl salicylate, purified water
  • PRINCIPAL DISPLAY PANEL

    Package label
    image of package label

  • INGREDIENTS AND APPEARANCE
    DIVAS  WINTERGREEN
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51444-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51444-005-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/26/2010
    Labeler - JMD All Star Impex Inc (962316662)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt.Ltd.650493005manufacture
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