Label: ISOPROPYL ALCOHOL- alcohol spray

  • NDC Code(s): 35418-402-10, 35418-402-12
  • Packager: Zee Medical
  • 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 December 11, 2017

If you are a consumer or patient please visit this version.

  • Active ingredient

    Isopropyl alcohol 70%

  • Purpose

    First aid antiseptic

  • Uses

    first aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only


    Flammable

    Caution: FLAMMABLE. Keep away from fire, flame or heat

    Do not use

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

    Ask a doctor before use if you have a

    • deep wound
    • puncture wound
    • animal bite
    • serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse

    Keep out of the reach of children

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

  • Directions

    • clean the affected area
    • spray a small amount of this product in the area 1 to 3 times daily
    • may be covered with a sterile bandage. If bandaged, let dry first
  • Other information

    • store at room temperature
    • this product is not made from ethyl or grain alcohol and it is not intended as a  substitute
  • Inactive ingredient

    purified water

  • Questions?

    1-800-841-8417   or zeemedical.com

  • Principal Display Panel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-402-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/08/2010
    2NDC:35418-402-12118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/08/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/08/2010
    Labeler - Zee Medical (009645623)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(35418-402)