ISOPROPYL ALCOHOL SPRAY [PROVISION MEDICAL]

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ISOPROPYL ALCOHOL SPRAY [PROVISION MEDICAL]
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NDC 69103-3502-1
Set ID 0720eb48-6588-4aca-89b5-54043e380659
Category HUMAN OTC DRUG LABEL
Packager Provision Medical
Generic Name
Product Class
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Isopropyl Alcohol 70.0%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only. Flammable keep away from fire or flame

    Do not use

    • near eyes or mucous membranes
    • on deep or puncture wounds, animal bites, or serious burns consult a physician

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Caution

    • not for use on large areas of the body
    • if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician
  • Directions

    • spray over cleaned affected area 1 to 3 times daily
    • if bandaged, let dry first
  • Inactive ingredients

    purified water

  • Principal Display Panel - Bottle Label

    ISOPROPYL
    ALCOHOL

    Caution: Flammable

    For External Use Only - If Taken Internally
    Serious Gastric Disturbances Will Result

    Package Not Child Resistant

    2 fl. oz. (59.15ml)

    Manufactured for

    Provision Medical Products Palm Desert, CA 92211

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    isopropyl alcohol (UNII: ND2M416302) (isopropyl alcohol - UNII:ND2M416302) isopropyl alcohol700 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-3502-10.05915 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-3502)
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