Label: HAND SANITIZING WIPES- alcohol 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 3, 2020

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  • Active Ingredient

    Ethyl alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Sanitizing wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Flammable. Keep away from heat or flame. For external use only. Not for use as a baby wipe.

  • Do not use

    • on children less than 2 months of age
    • on damaged or sensitive skin
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

  • 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.

  • Directions

    • Remove wipe from package. Reseal package to prevent wipes from drying out. Then apply wipe to hands and clean thoroughly.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Glycerol, Aloe extract, Sodium Hyaluronate, Trolamine, Water (aqua), Denatonium

  • Package Label - Principal Display Panel

    Principal Display PanelPouchCarton

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74035-2051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74035-2051-24 in 1 CARTON09/03/2020
    1NDC:74035-2051-150 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2020
    Labeler - SUMEC Hardware & Tools Co., Ltd. (654687771)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUMEC Hardware & Tools Co., Ltd.654687771manufacture(74035-2051) , label(74035-2051)
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