Label: HAND SANITIZER- alcohol liquid

  • 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 May 23, 2020

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  • Active Ingredient

    Alcohol 80%

  • Purpose

    Antiseptic

  • Uses

    ■ 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 fire and flame.

  • Do not use

    ■ on 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 throughly with water.

  • Stop use and ask a doctor if

    irritation and redness develops and persists.

  • Keep out of reach of children

    If swallowed, contact a doctor or Poison Control Center right away.

  • Directions

    ■ Apply a dime sized amount to hands. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    Store between 59-86ºF. Avoid freezing and excessive heat above 104ºF

  • Inactive ingredients

    Water, Acrylates Copolymer, Glycerin, Aminomethyl Propanol, Aloe Vera (Aloe Barbadensis) Leaf Extract, Tocopheryl Acetate (Vitamin E), Pichia/Resveratrol Ferment Extract

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76383-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    RESVERATROL (UNII: Q369O8926L)  
    PICHIA JADINII (UNII: 8JRL032K80)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76383-024-18550 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/28/2020
    Labeler - BBC GROUP LIMITED (421270060)
    Establishment
    NameAddressID/FEIBusiness Operations
    BBC GROUP LIMITED421270060manufacture(76383-024)
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