Label: DEZINFEKCE DISINFECTANT- hypochlorous acid disinfectant liquid

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

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

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

  • Active Ingredient(s)

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

  • Purpose

    The product can kill common bacteria in hospital infection, pathogenic entero becteria, pyogenic coccus, pathogenic yeast, escherichia coli, staphylococcus aureus, pseudomonas aeruginosa, candida albicans, bacillus subtilis var. niger spores and other microorganisms.

  • Use

    Use the product to spray, wipe, soak for disinfection. Air dry is recommended and here is no need for secondary cleaning.

    Scope of application:

    Surface disinfection: spray and wipe to disinfect stair handrails, door handles, desktop, seats, floors, etc.;

    Disinfection of fruits and vegetables: soak fruits and vegetables to disinfect and kill surface microorganisms.

  • 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

    1. Surface disinfection of hard objects: Use the stock solution to wipe and disinfect, act for 20 minutes, and air-dry naturally without secondary cleaning.

    2. Disinfection of food and drinking utensils: Soak it in the product for 30 minutes and then take it out, and air-dry naturally without secondary cleaning.

    3. Air disinfection: Use the stock solution to atomize the indoor air at an amount of 10mL/m3 for 30 minutes.

  • Other information

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

  • Inactive ingredients

    Sodium chloride, Water

  • Package Label - Principal Display Panel

    L25

  • INGREDIENTS AND APPEARANCE
    DEZINFEKCE DISINFECTANT 
    hypochlorous acid disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75316-125
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID17.5 g  in 25 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75316-125-1632 in 1 TRAY04/23/2020
    1NDC:75316-125-0125 L in 1 DRUM; 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(75316-125) , manufacture(75316-125)