Label: 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 September 28, 2020

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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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