Label: FVJIA DISINFECTANT- didecyl dimethyl ammonium chloride, benzalkonium chloride spray

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 18, 2022

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  • SPL UNCLASSIFIED SECTION

    FVJIA disinfectant

  • Active Ingredient(s)

    Didecyl Dimethyl Ammonium Chloride 0.60g/100mL

    Benzalkonium chloride 0.20g/100mL

  • Purpose

    Antiseptic

  • Use

    FVJIA disinfectant to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Spray on the surface of the skin and let it dry naturally
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Polyhexamethylene biguanide hydrochloride
    Distilled water
    Glutaric dialdehyde

  • Package Label - Principal Display Panel

    123

  • INGREDIENTS AND APPEARANCE
    FVJIA DISINFECTANT 
    didecyl dimethyl ammonium chloride, benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82170-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 mL
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    GLUTARALDEHYDE (UNII: T3C89M417N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82170-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
    2NDC:82170-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
    3NDC:82170-101-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product08/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/18/2021
    Labeler - Hunan Fujia Environmental Safety Technology Co., Ltd (711713369)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hunan Fujia Environmental Safety Technology Co., Ltd711713369manufacture(82170-101)
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