Label: FRESH AND CLEAN HAND SANITIZER- antibacterial 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 July 9, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient - Ethyl Alcohol 65%.....Antiseptic

  • PURPOSE

    Purpose - Antiseptic

  • Use

    To decrease bacteria on hands 

  • Warnings

    For external use only

    Flammable, keep away from fire or flame

  • Keep out of reach of children

    If accidently swallowed, get medical help or contact a Poison Control Center right away

  • WHEN USING SECTION

    Keep out of eyes,In case of contact flush eyes with water.

    Avoid contact with broken skin.

  • ASK DOCTOR

    Discontinue use if irritation or redness develop. 

  • Directions

    • Rub hands thoroughly with product and allow to dry.
  • Inactive Ingredients

      Water,  Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Parfum ,Aloe bardadensis Leaf Extract,

    PEG-40 Hydrogenated Castor Oil, Tocopherol Acetate , Avena Sativa(Oat) Kernal Extract.

  • PRINCIPAL DISPLAY PANEL

    sani13

  • INGREDIENTS AND APPEARANCE
    FRESH AND CLEAN HAND SANITIZER 
    antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71246-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    OAT (UNII: Z6J799EAJK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71246-0013-659.14 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/06/2020
    Labeler - JFL Enterprises, Inc. (010967011)
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