Label: HAND SANITIZER 2OZ 2PK WITH ALOE VERA- ethyl alcohol 70% gel

  • NDC Code(s): 57337-143-01, 57337-143-02
  • Packager: Rejoice International Corp.
  • 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 September 10, 2023

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  • Active ingredient

    Ethyl Alcohol 70% V/V

  • Purpose

    Antimicrobial

  • Uses

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from heat and flame

    Do not use

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

    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.

  • Directions

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children under 6 years in the use of this product
  • Other inofrmation

    • store at room temperature
    • may discolor certain fabrics
  • Inactive ingredients

    water

    carbomer

    glycerin

    propylene glycol

    aminomethyl propanol

    fragrance

    aloe barbadensis leaf juice

    tocopheryl acetate

    fd&c blue no.1

    fd&c yellow no.5

  • Label

    label 1

    label 2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 2OZ 2PK WITH ALOE VERA 
    ethyl alcohol 70% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-143
    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
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-143-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2023
    2NDC:57337-143-022 in 1 BOX09/10/2023
    259 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/10/2023
    Labeler - Rejoice International Corp. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Guoyao Jingyue Aerosol Co., Ltd.554529812manufacture(57337-143)
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