Label: 75% ALCOHOL DISINFECTANT 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 May 18, 2020

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  • Active Ingredient

    Ethyl alcohol 75%(V/V)

  • Purpose

    Antimicrobial

  • Use

    Ethanol disinfectant to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available

  • WARNINGS

    Flammable, keep away from fire or flame.For external use only.

  • DO NOT USE

  • When using this product

    do not use in or near the eyes, In case of contact, rinse eyes thoroughly with water.

    Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.

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

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry.

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

  • Other information

    Store below 106°F.(41℃)

    May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Water.

  • Package Label - Principal Display Panel

    60 ml label 100 ml label 120 ml label 250 ml label 300 ml label 500 ml label 750 ml label 1000 ml label 4000 ml label 5000 ml label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL DISINFECTANT 
    75% alcohol disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78295-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78295-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    2NDC:78295-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    3NDC:78295-001-03120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    4NDC:78295-001-04250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    5NDC:78295-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    6NDC:78295-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    7NDC:78295-001-07750 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    8NDC:78295-001-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    9NDC:78295-001-094000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    10NDC:78295-001-105000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/18/2020
    Labeler - GUANGZHOU YIQI TECHNOLOGY CO.,LTD (544707398)
    Registrant - GUANGZHOU YIQI TECHNOLOGY CO.,LTD (544707398)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU YIQI TECHNOLOGY CO.,LTD544707398manufacture(78295-001)
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