Label: ISOPROPYL ALCOHOL ANTISEPTIC- isopropyl alcohol spray

  • 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 October 6, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Isopropyl Alcohol 70.0%

  • Purpose

    First Aid Antiseptic

  • Uses

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

  • Warnings

    For external use only.

    Flammable keep away from fire or flame.

    Do not use

    • in the eyes
    • over larger areas of the body
    • longer than 1 week unless directed by a doctor

    Keep out of reach of children If swallowed get medical help or contact Poison Control Center right away

    Stop use and ask a doctor

    • in case of deep puncture wounds, animal bites, or serious burns
    • if condition persists or gets worse
  • Directions

    • spray a small amount over cleaned affected area 1 to 3 times daily
    • if bandaged, let dry first
  • Inactive ingredient

    purified water

  • Principal Display Panel - Bottle Label

    13-030

    ANTISEPTICS

    FIRST AID ONLY®

    Isopropyl Alcohol
    Antiseptic Spray

    Antiseptic first aid spray
    for use on minor cuts,
    scrapes and burns

    4 fl oz (118.3ml)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL ANTISEPTIC 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0933
    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:0924-0933-010.1183 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 finalpart333A10/06/2014
    Labeler - Acme United Corp (001180207)
    Registrant - Safetec of America, Inc (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(0924-0933)
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