Label: HAND SANITIZER 2OZ 2PK ORIGINAL- ethyl alcohol gel

  • NDC Code(s): 57337-148-01, 57337-148-02
  • Packager: Rejoice International Corp.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 4, 2023

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  • Active ingredient

    Ethyl Alcohol 70.0%v/v

  • Purpose

    Antimicrobial

  • Uses

    For hand washing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only

    Flammable, keep away from heat and flame.

    Stop use and ask a doctor if

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

    Do not use

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

  • Directions

    wet hands thoroughly with product

    Briskly rub hands together until dry

    Supervise children under 6 years in the use of this product

  • Other information

    Store at room temperature

    May discolor certain fabrics

  • Inactive ingredients

    water

    carbomer

    glycerin

    propylene glycol

    aminomethyl propanol

    fragrance

    aloe barbadensis leaf juice

    tocopheryl acetate

  • label

    label1label2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 2OZ 2PK ORIGINAL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-148
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-148-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/04/2023
    2NDC:57337-148-022 in 1 BOX10/04/2023
    259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/04/2023
    Labeler - Rejoice International Corp. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Guoyao Jingyue Aerosol Co., Ltd.554529812manufacture(57337-148)
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