Label: ALCOHOL- 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 January 31, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                                       Purpose

    Isopropyl Alcohol 99% v/v                         Antiseptic

  • PURPOSE

    First aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • WARNINGS

    • For external use only
    • Flammable, keep away from fire or flame, heat, spark, electrical.
    • Not for use with electrocautinary devices or procedures
    • Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
    • Stop use and ask a doctor if condition persist or gets worse.

    For rubbing and massaging:

    • Caution: Do not apply to irritated skinor if excessive irritation develops
    • Avoid getting into eyes or mucous membranes
  • INDICATIONS & USAGE

    When using this product:

    • do not get in eyes
    • do not apply over large areas of the body
    • do not use longer than 1 week unless directed by a doctor
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    IIf 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 affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged let dry first

  • OTHER INFORMATION

    • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
    • avoid excessive heat
    • Does not contain, nor is it intended as a substitute for grain or ethyl alcohol
    • Will produce serious gastric disturbances if taken internally
  • INACTIVE INGREDIENT

    Inactive Ingredient

    • Water
  • PRINCIPAL DISPLAY PANEL

    DYNAREX 99% ISOPROPYL ALCOHOL

    99 IPA BP.jpg

    IPA 99

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.99 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-305-01473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/29/2014
    Labeler - Blossom Pharmaceuticals (677381470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blossom Pharmaceuticals677381470manufacture(61767-305)
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