Label: JUSOFON HAND SANITIZER- alcohol gel

  • NDC Code(s): 56136-310-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • 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 30, 2020

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

  • Drug Facts

  • Active ingredient

    Alcohol 75% ±5%(V/V)

  • Purpose

     Antiseptic

  • Use

    Decrease bacteria on hands.

  • Warnings

    For external use only.

    Flammable.Keep product away from fire or flame.

    Stop use and ask a doctor if

    irritation or redness develops and persists.

    Warning-Choking Hazard

    Small parts, not for children under 3 years.

    Keep out of reach of children.

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

    Small Parts. Not for children under 3 years.

  • Directions

    Wet hands thoroughly with product and allow to dry.

  • Inactive ingredients

    Alcohol Denat, Water (Aqua), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    JUSOFON HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-310
    Route of AdministrationTOPICAL
    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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-310-01500 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 - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Registrant - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-310)