Label: ENTIERE HAND SANITIZER- alcohol gel

  • NDC Code(s): 64987-0323-6
  • Packager: World Club Supply Corp
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 26, 2023

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  • Drug Facts

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v

    Purpose

    Antimicrobial

  • Use(s)

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

  • 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.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

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

  • Inactive Ingredients

    Purified Water, Glycerin, Hydrogen Peroxide, Carbomer, Isopropyl Myristate, Triethanolamine, Polysorbate, Fragrance

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ENTIERE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64987-0323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64987-0323-63.78 L in 1 BOTTLE; Type 0: Not a Combination Product11/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/28/2022
    Labeler - World Club Supply Corp (061098208)
    Establishment
    NameAddressID/FEIBusiness Operations
    World Club Supply Corp061098208manufacture(64987-0323)
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