Label: EKO DISINFECTANT- hypochlorous acid liquid

  • Contains inactivated NDC Code(s)
    NDC Code(s):     77756-001-01, 77756-001-02, 77756-001-03, 77756-001-04, view more
    77756-001-05, 77756-001-06, 77756-001-07, 77756-001-08, 77756-001-09, 77756-001-10, 77756-001-11
  • Packager: Heming (Shanghai) Environmental Technology Co., Ltd.
  • 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 May 12, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. HYPOCHLOROUS ACID (0.02%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    HYPOCHLOROUS ACID 0.02 %

  • Purpose

    Disinfectant.

  • Use

    This product is suitable for disinfection of tableware, food processing tools and equipment, fruits and vegestables, hands and indoor air.

  • Warnings

    For external use only. Do not mix with other alkaline or strong acid preparations.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • 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)
    • Please keep away from direct sunlight and high temperature and keep in a cool place
  • Inactive ingredients

    purified water USP

  • Package Label - Principal Display Panel

    30ml NDC: 77756-001-01 EKO1EKO2

  • INGREDIENTS AND APPEARANCE
    EKO DISINFECTANT 
    hypochlorous acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77756-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID200 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77756-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:77756-001-0398 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:77756-001-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:77756-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:77756-001-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:77756-001-085000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:77756-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:77756-001-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:77756-001-0920000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    10NDC:77756-001-1025000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    11NDC:77756-001-111000000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Heming (Shanghai) Environmental Technology Co., Ltd. (554533962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heming (Shanghai) Environmental Technology Co., Ltd.554533962manufacture(77756-001)
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