Label: JINHUI ALCOHOL-BASED HAND SANITIZER- hand sanitizer 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 April 8, 2020

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  • DOSAGE & ADMINISTRATION

    Keep away from flame or fire.

  • INACTIVE INGREDIENT

    PCMX

    Water

    Propanol

    Glycerol

    Triethanolamine

    Carbomer

    Sodium Hyaluronate

  • INDICATIONS & USAGE

    Squeeze out the hand sanitizer and apply it to your hands,rub evenly until dry.

  • ACTIVE INGREDIENT

    Ethyl Alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1. For external use only, not for oral. Keep out of reach of children.
    2. This product should not be applied on the cyelids or directly into the eyes. In case of contact, rinse eyes thoroughly with water.
    3. Flammable. Keep away from flame or fire.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    JINHUI ALCOHOL-BASED HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65377-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL300 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    PROPYL ALCOHOL (UNII: 96F264O9SV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65377-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2020
    Labeler - Tianjin Jinhui Pharmaceutical Group Co., Ltd. (653771522)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tianjin Jinhui Pharmaceutical Group Co., Ltd.653771522manufacture(65377-001)
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