Label: 77 DISINFECTION ETHANOL LIQUI D- 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 11, 2020

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  • ACTIVE INGREDIENT

    Alcohol 83% v/v

  • INACTIVE INGREDIENT

    Water

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in children less than 2 months of age
    • on open skin wounds
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    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.

  • Uses

    • disinfection of hard object surfaces

  • Directions

    • Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
    • Supervise children in the use of this product.

  • Other information

    • Store between 59-86℉ (15-30℃)
    • Avoid freezing and excessive heat above 104℉ (40℃)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    77 DISINFECTION ETHANOL LIQUI D 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80454-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol415 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80454-010-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2020
    Labeler - SUNGSUBIOTEK CO. LTD. (690452683)
    Registrant - SUNGSUBIOTEK CO. LTD. (690452683)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUNGSUBIOTEK CO. LTD.690452683manufacture(80454-010)
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