Label: HAND SANITIZER GEL 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 November 2, 2020

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

  • STORAGE AND HANDLING

    Store below 40°C (100°F).

  • INACTIVE INGREDIENT

    Water

    Glycerin

    Carbomer

    Triethanolamine

  • INDICATIONS & USAGE

    Highly effective alcohol based hand sanitizing gel which sanitizes the skin without theneed for water.Gel désinfectant pour les mains tres efficace a base d'alcool qui désinfecte la peau sans necessiter d'eau.

  • ACTIVE INGREDIENT

    Alcohol

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. lf swallowed, call a Poison Control Centre or a doctor.

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only.Keep away from flame and heat. Stop use and ask a doctor if irritation develops.

  • PRINCIPAL DISPLAY PANEL

    070605040302label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55467-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mL  in 946 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55467-016-01946 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    2NDC:55467-016-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    3NDC:55467-016-03236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    4NDC:55467-016-04300 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    5NDC:55467-016-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    6NDC:55467-016-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    7NDC:55467-016-073780 mL in 1 BOTTLE; Type 0: Not a Combination Product11/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/03/2020
    Labeler - GUANGDONG INTENTLY BIOTECHNOLOGY CO.,LTD. (554531968)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGDONG INTENTLY BIOTECHNOLOGY CO.,LTD.554531968manufacture(55467-016)