Label: 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 September 27, 2013

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  • Isopropyl Alcohol

    Active IngredientIsopropyl Alcohol 70 percent

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  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses 
    First aid to help prevent skin infection in minor
    cuts and scrapes

  • WARNINGS

    For External Use Only.  If taken internally serious gastric

    disturbances will result.

  • DO NOT USE

    Do not use in the eyes or apply over large areas of the

    body.  In case of deep or puncture wounds, animal bites,

    or serious burns, consult a doctor.

    Do not use longer than 1 week, unless directed by a

    doctor.

  • STOP USE

    Stop use and consult a doctor if condition persists or gets

    worse.

  • OTHER SAFETY INFORMATION

    Flamable.  Keep away from fire or flame.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.  If swallowed, get

    medical help or contact a Poison Control Center right

    away.

  • DOSAGE & ADMINISTRATION

    Directions  clean the affected area  apply a

    small amount of this product on the area 1 to 3 times daily

    may be covered with a sterile bandage   if bandaged, let

    dry first

  • INACTIVE INGREDIENT

    Inactive ingredients   methyl isobutyl ketone

  • Isopropyl Alcohol 70% by Volume

    ALCOHOL

    ISOPROPILICO

    70%

    ANTISEPTICO

    ISOPROPYL

    ALCOHOL

    70%

    BY VOLUME

    FIRST AID ANTISEPTIC

    Jaloma

    PRODUCT OF MEXICO

    7.5 FL OZ (224 mL)

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  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    methyl isobutyl ketone (UNII: U5T7B88CNP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-601-01224 mL in 1 BOTTLE, PLASTIC
    2NDC:65055-601-02448 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/27/2013
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-601)
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