Label: EAAE DISINFECTANT- alcohol gel

  • 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 April 22, 2020

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  • ACTIVE INGREDIENT

    Alcohol 75% 

  • Purpose

    Antibacterial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only.

    Non Medical. Flammable. Keep away from fire or flame

    When using this product, do not use in or near eyes, In case of contact, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts

  • 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

    • Put enough products on your palm to cover hands and rub hands together briskly until dry
  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Perfume, Castor Oil, Hydrogenated, ethoxylated

  • 60 mL

    image description

  • 300 mL

    image description

  • 500 mL

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  • INGREDIENTS AND APPEARANCE
    EAAE DISINFECTANT 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71004-101
    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
    CARBOMER 934 (UNII: Z135WT9208)  
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71004-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    2NDC:71004-101-02300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    3NDC:71004-101-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2020
    Labeler - iHotel Guest Amenities Co.,Ltd (421299845)
    Establishment
    NameAddressID/FEIBusiness Operations
    iHotel Guest Amenities Co.,Ltd421299845manufacture(71004-101)
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