Label: 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 23, 2020

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  • DOSAGE & ADMINISTRATION

    keep away from fire sources;avoid direct sunlight

  • INACTIVE INGREDIENT

    AQUA、GLYCERIN、CARBOMER、4- AMINOBENZYL ALCOHOL

  • INDICATIONS & USAGE

    get some the product on your palm, evenly smear the hands the required part, and wait for the natural volatilization.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Mild cleansing
    Quick drying without washing
    Wipe off germs
    Protect family health

  • WARNINGS

    for external use only;keep awayfrom fire sources;avoid direct sunlight vand place in a cool place. In case of eye contact,rinse with water immediately ;incase of alcohol allergy, use with caution ;do not eat; children should use it under the guidance of adults.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54096-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    M-AMINOBENZYL ALCOHOL (UNII: KN96ABQ0SP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize70mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54096-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - Dongyang Caiyi Cosmetics Co., Ltd. (540964712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongyang Caiyi Cosmetics Co., Ltd.540964712manufacture(54096-001)