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

  • NDC Code(s): 82170-101-01, 82170-101-02, 82170-101-03
  • Packager: Hunan Fujia Environmental Safety Technology 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 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)