ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]

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ISOPROPYL ALCOHOL SPRAY [SAFETEC OF AMERICA, INC.]
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NDC 61010-5500-2
Set ID 89310a64-c4cc-46c6-8294-c4d28cd88118
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
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

    Keep out of reach of children.

    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
  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

    NDC 61010-5500-2

    Safetec

    Isopropyl
    Alcohol Spray

    First Aid to Help
    Prevent Infection in
    Minor Cuts, Scrapes
    and Burns.

    2 fl. oz. (59.1ml)
    Reorder no. 53002

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5500
    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
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5500-259.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/16/2012
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-5500)
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