Label: ALCOHOL- 74021-0007 liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 1, 2020

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  • ACTIVE INGREDIENT

    Alcohol 80% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

  • DO NOT USE

    • in children less than 2 months of age
    • on open skin wounds

  • STOP USE

    . Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • DOSAGE & ADMINISTRATION

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER SAFETY INFORMATION

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    glycerin, hydrogen peroxide, purified water USP

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    74021-0007 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74021-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74021-0007-1750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/25/2020
    Labeler - Bacardi Bottling Corporation (061916110)
    Registrant - Bacardi Bottling Corporation (061916110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bacardi Bottling Corporation061916110manufacture(74021-0007)
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