ISOPROPYL ALCOHOL LIQUID [AFASSCO INC.]

ISOPROPYL ALCOHOL LIQUID [AFASSCO INC.]
PDF | XML

NDC 51532-5500-1
Set ID 3c0dcbb0-04f3-46e7-9e92-721862c59341
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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

    Isopropyl
    Alcohol
    Spray

    First Aid Antiseptic Spray

    Caution: FLAMMABLE

    • Cleans Minor Cuts and Abrasions
    • Provides Cooling Affect
    • Fights Infection

    #629 2 Fl. Oz. (59 mL)

    Mfd. For
    Afassco
    MINDEN, NV 89423

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-5500
    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:51532-5500-10.059 L 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 - Afassco Inc. (609982723)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(51532-5500)

Related Drugs