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 September 14, 2020

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  • Active Ingredient

    Ethanol 75%

  • Purpose

    Antiseptic

  • Use

    Wipe on skin to help reduce bacteria on skin that potentially can cause diseas

  • Warnings

    For external use only
    Flammable, keep away from heat or fame

  • Do not use

    On children less than 2 montns of age

  • 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 doctor

    irritation or rash occurs, These may be signs of a senous condition.

  • Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away

  • Directions

    Rub hands on wipe
    and use to disinfect
    Supervise children under 6 years of age when using ths product.

  • Other information

    Store below 43C (110F

  • Inactive Ingredients

    aloe vera extract, glycerol, purified water.

  • Package Label - Principal Display Panel

    78959-002-03 578959-002-04 10150

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPES 
    alcohol wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78959-002
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78959-002-011 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    2NDC:78959-002-0250 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    3NDC:78959-002-035 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
    4NDC:78959-002-0410 in 1 PACKAGE; 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(78959-002)
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