Label: INSTANT HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 57337-018-01, 57337-018-02
  • Packager: Rejoice International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Ethyl Alcohol 62.0%......................Antimicrobial

  • PURPOSE

    XtraCare Instant Hand Sanitizer - Original

    Kills 99.9% of Germs with Moisturizers & Vitamin E

  • 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.

  • INDICATIONS & USAGE

    USE: 

    • hand sanitizer to help reduce bacteria on the skin that may cause disease
  • WARNINGS

    Warnings:

    for external use only.

    Flammable. Keep away from heat and flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Directions:

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • children under 6 years of age should be supervised by an adult when using.
  • INACTIVE INGREDIENT

    Inactive ingredients:

    carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.

  • PRINCIPAL DISPLAY PANEL

    bottle label

    package label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL6 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-018-022 in 1 PACKAGE07/05/2013
    1NDC:57337-018-0110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/05/2013
    Labeler - Rejoice International, Inc. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-018)
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