Label: IDO DISINFECTION ETHANOL- ethanol liquid

  • 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 August 4, 2022

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  • ACTIVE INGREDIENT

    ethanol

  • INACTIVE INGREDIENT

    Water

  • PURPOSE

    First aid to help prevent the risk of infection in minor cuts, scrapes or burns.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    For the external use only

  • WARNINGS

    For external use only

    • If taken internally, serious gastric disturbances will result
    • flammable, keep away from heat or flame

    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

    When using this product

    • do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if irritation or rash appears

    Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center 1-800-222-1222 or dial 911 immediately

  • DOSAGE & ADMINISTRATION

    Clean affected area

    Apply small amount of this product on the affected area 1-3 times daily

    May be covered with a sterile bandage. If bandaged, let dry first

    children under 6 years of age should be supervised when using this product

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    IDO DISINFECTION ETHANOL 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77039-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL83 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77039-022-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2022
    Labeler - IDO PHARM (694853523)
    Registrant - IDO PHARM (694853523)
    Establishment
    NameAddressID/FEIBusiness Operations
    IDO PHARM694853523manufacture(77039-022)
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