Label: ADVANCED HAND SANITIZER- alcohol solution

  • Category: HUMAN OTC DRUG LABEL

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 January 4, 2022

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  • SPL UNCLASSIFIED SECTION

    NA

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin that may cause disease

  • Warnings

    For external use only

    Flammable. Keep away from heat and flame

  • WHEN USING

    When using this product aviod contact with face, eyes and broken skin. In case of contact, flush with plenty of water and seek medical advice

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops

  • 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

    • Wet hands thoroughly with product and rub into skin until dry
    • Children under 6 years of age should be supervised by an adult when using
  • Inactive ingredients

    Water, triethanolamine, carbomer, aloe barbadensis (aloe vera) gel, fragrance, propylene glycol, glycerin, tocopheryl acetate (Vitamin E)

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76860-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76860-001-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2020
    2NDC:76860-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    Labeler - Taizhou Huangyan Liweir Cosmetic Technology LTD (560781517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Huangyan Liweir Cosmetic Technology LTD560781517manufacture(76860-001)
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