Label: OKGO DISINFECTANT- didecyl dimethyl ammonium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 25, 2021

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  • SPL UNCLASSIFIED SECTION

    OKGO®Disinfectant

  • Active Ingredient(s)

    Didecyl dimethyl ammonium chloride 0.5g/L. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    OKGO®Disinfectant to help reduce bacteria that potentially can cause disease.

  • 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 human skin and let it dry naturally.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Fatty alcohol polyoxyethylene ether
    Dimethyldioctylammonium chloride
    Dodecyldimethylbenzylammonium chloride
    Benzyldimethylhexadecylammonium chloride
    essence
    water
    Alkyl indican
    triethanolamine

  • Package Label - Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    OKGO DISINFECTANT 
    didecyl dimethyl ammonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81476-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM (UNII: 7N6JUD5X6Y)  
    (C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    DIOCTYLDIMONIUM CHLORIDE (UNII: 0X0RL40Y6H)  
    WATER (UNII: 059QF0KO0R)  
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81476-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2021
    2NDC:81476-101-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2021
    3NDC:81476-101-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2021
    4NDC:81476-101-04450 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/26/2021
    Labeler - Henan Seagood Medical Equipment Co., Ltd. (715343285)
    Establishment
    NameAddressID/FEIBusiness Operations
    Henan Seagood Medical Equipment Co., Ltd.715343285manufacture(81476-101)
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