Label: HAND SANITZER- ethyl 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 January 12, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 74% v/v

  • Purpose

    Ethyl Alcohol 74% v/v................Antiseptic

  • Uses

    highly effective alcohol-based hand sanitizing gel which sanitizes the skin without the need for water.

  • Warnings

    For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. If swallowed, call a Poison Control Centre or a doctor. Supervise children using this product.

  • WARNINGS

    Flammable. Keep away from flame and heat.

  • STOP USE

    Stop use and ask a doctor if irritation develops

  • WARNINGS

    Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • Directions

    Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry

  • Other Information

    Store below 40°C (100°F).

  • Inactive Ingredients

    water, glycerin, carbomer, triethanolamine

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    HAND SANITZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80511-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL740 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80511-001-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    2NDC:80511-001-0380 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    3NDC:80511-001-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    4NDC:80511-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    5NDC:80511-001-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    6NDC:80511-001-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    7NDC:80511-001-073780 mL in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/04/2020
    Labeler - Luxe Decor Sales Ltd (204166933)
    Registrant - Luxe Decor Sales Ltd (204166933)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGDONG INTENTLY BIOTECHNOLOGY CO., LTD.554531968manufacture(80511-001)
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