Label: DEZINFEKCE DISINFECTANT- hypochlorous acid disinfectant liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 23, 2020

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  • Active Ingredient(s)

    Hypochlorous acid 700 mg/L. Purpose: Kill microorganism.

  • Purpose

    Rinse-free hand disinfectant in daily life, which is suitable for children and adults; Hand disinfection for medical staff.

    The product can kill staphylococcus aureus, escherichia coli and candida albicans.

  • Use

    Spray appropriate amount of the product on hands and rub them until dry.

  • Warnings

    External Use Only

    •Do not replace containers

    •Do not mix it with other disinfection products

    •Keep it sealed, and use it as soon as possible after unpacking

    •Spraying on the fabrics is not recommended

    •Not suitable for articles made of copper or carbon steel

    •Keep out of reach children

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • mixing this product with other disinfectants
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

    This product is for external use. It should not be taken orally.

    This product has a certain corrosive effect on metal objects other than stainless steel, and should be used with caution.

    When sterilizing articles containing more organic objects, they should be completely removed and then disinfected.

    Use with caution for those with sensitive skin.

    Do not mix this product with other disinfectants.

  • 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

  • Directions

    Spray appropriate amount of the product on hands and rub them until dry

  • Other information

    Storage: place it in a normal temperature and light-shielded environment.

  • Inactive ingredients

    Sodium chloride, Water

  • Package Label - Principal Display Panel

    300

  • INGREDIENTS AND APPEARANCE
    DEZINFEKCE DISINFECTANT 
    hypochlorous acid disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75316-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID210 mg  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75316-103-1520 in 1 CARTON04/23/2020
    1NDC:75316-103-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/23/2020
    Labeler - Shanghai Jiyi Biological Technology Co., Ltd. (554529167)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Jiyi Biological Technology Co., Ltd.554529167label(75316-103) , manufacture(75316-103)