Label: SUFIYA (hocl- hypochlorous acid 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 December 29, 2022

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  • Active ingredient[s]

    HOCl (Hypochlorous acid) 0.1%

  • Purpose

    Disinfect, deodorization

  • Use[s]

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

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • for any other purpose
    • in children less than 2 months of ago
    • on open skin wounds
  • 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 any abnormality occurs on the skin.

  • Keep out of reach of children.

    If swallowed, drink enough water and get medical help or contact a Poison Control Center right away.

  • Directions

    • Spray from a distance of 4-8 inches where sterilization, disinfection, and deodorization are required
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C(58-86F)
    • Avoid freezing and excessive heat above 40C(104F)
    • If medical treatment is required, look at the product container or labeling information.
  • Inactive ingredients

    Purified water

  • Package Label

    82124-701

  • INGREDIENTS AND APPEARANCE
    SUFIYA 
    hocl(hypochlorous acid) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82124-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82124-701-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2021
    2NDC:82124-701-02600 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/20/2021
    3NDC:82124-701-031000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/20/2021
    Labeler - EMSOLUTION Co., Ltd (694603987)
    Registrant - EMSOLUTION Co., Ltd (694603987)
    Establishment
    NameAddressID/FEIBusiness Operations
    EMSOLUTION Co., Ltd694603987manufacture(82124-701)