Label: ALCOHOL WIPES cloth

  • 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, 2020

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  • Active Ingredient

    Ethyl alcohol 75%.v/v

  • Purpose

    Antimicrobial

  • Use

    decreases bacteria on skin.

  • Warnings

    For external use only.

    Flammable.Keep away from fire or flame.

  • Do not use

    if you are allergic to any of the ingredients.

  • When using this product

    do not get into eyes.In case of contact,rinse thoroughly with water.

  • Stop use and ask doctor

    if irritation or rash develops and continues for more than 72 hours.

  • Keep out of reach of children

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

  • Directions

    Adults and children apply to hands.

    Children under 6 years of age should be supervised when using HY 2 years and over.

  • Other information

  • Inactive Ingredients

    Ro pure water, Double-chain quaternary ammonium salt.

  • Package Label - Principal Display Panel

    78959-001-05 8078959-001-0178959-001-0278959-001-03 178959-001-03 278959-001-0478959-001-0678959-001-07 178959-001-07 278959-001-08

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78959-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78959-001-011 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    2NDC:78959-001-0210 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    3NDC:78959-001-0350 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    4NDC:78959-001-0460 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    5NDC:78959-001-0580 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    6NDC:78959-001-06100 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    7NDC:78959-001-0760 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    8NDC:78959-001-0880 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    9NDC:78959-001-09100 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/16/2020
    Labeler - Weifang Yujie Disinfectant Co. , Ltd. (545098868)
    Registrant - Weifang Yujie Disinfectant Co. , Ltd. (545098868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weifang Yujie Disinfectant Co. , Ltd.545098868manufacture(78959-001)
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