Label: THE VILLAGES HAND SANITIZER WITH ALOE AND VITAMIN E EXTRACT- alcohol solution

  • 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 June 23, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% 

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only.

    Non Medical. Flammable. Keep away from fire or flame

    Do not use in or near eyes, In case of contact, rinse thoroughly with water

  • STOP USE

    Stop use and consult a doctor if irritation or rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek immediate medical help or contact a poison control center

  • Directions

    • Apply literally to the hands and rub until dry
  • Inactive ingredients

    Water, Carbomer, Triethanolamine, Glycerin, Alor Barbardensis Leaf Juice, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    THE VILLAGES HAND SANITIZER WITH ALOE AND VITAMIN E EXTRACT 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71004-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71004-103-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
    2NDC:71004-103-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/20/2020
    Labeler - iHotel Guest Amenities Co.,Ltd (421299845)
    Establishment
    NameAddressID/FEIBusiness Operations
    iHotel Guest Amenities Co.,Ltd421299845manufacture(71004-103)