Label: HAND SANIZITER- waterless hand sanitizer 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 24, 2020

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  • DOSAGE & ADMINISTRATION

    Flammable, keep away from fire or flame，Store at room temperature

  • INACTIVE INGREDIENT

    AQUA

    ACRYLATES COPOLYMER

    GLYCERIN

    PROPYLENE GLYCOL

    TREHALOSE

    TRIETHANOLAMINE

  • INDICATIONS & USAGE

    Dispense product evenly on palms or on material surface and allow dry

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1.For external use only,Avoid contact with eyes or wound, if product gets into eyes, rinse thoroughly with water
    2.Stop using this product if skin irritation occurs and consult a doctor immediately
    3.Keep out of reach of children If swallowed, seek medical help immediately
    4.Flammable, keep away from fire or flame
    5.Do not mix with detergents or other chemicals

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANIZITER 
    waterless hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54457-003
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2835 mL  in 3780 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TREHALOSE (UNII: B8WCK70T7I)  
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54457-003-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2020
    Labeler - Guangzhou Zunai Daily Cosmetics Co.,Ltd (544579961)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Zunai Daily Cosmetics Co.,Ltd544579961manufacture(54457-003)
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