Label: MUNDUS HYPOCHLOROUS ACID HAND SANITIZER liquid

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

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Drug Label Information

Updated March 14, 2022

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  • Active Ingredient(s)

    Hypochlorous acid 0.015%

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Used to wash hands to help reduce bacteria that potentially can cause disease.

  • Warnings

    • For external use only.
    • Keep away from heat.
  • 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

    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, ger 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 13-30℃.
    • Avoid freezing and excessive heat above 40℃.
  • Inactive ingredients

    Hypochlorite Ion, Sodium Chloride(Salt), lonized Water.

  • Package Label - Principal Display Panel

    480 mL NDC: 55683-003-01 480mL label

    100 mL NDC: 55683-003-02 100mL label

    25000 mL NDC: 55683-003-03 25000mL label

    10000 mL NDC: 55683-003-04 10000mL label

    60 mL NDC: 55683-003-05 60mL label

    80 mL NDC: 55683-003-06 80mL label

    300 mL NDC: 55683-003-07 300mL label

    500 mL NDC: 55683-003-08 500mL label

  • INGREDIENTS AND APPEARANCE
    MUNDUS HYPOCHLOROUS ACID HAND SANITIZER 
    mundus hypochlorous acid hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55683-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.015 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYPOCHLORITE ION (UNII: T5UM7HB19N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55683-003-01480 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    2NDC:55683-003-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    3NDC:55683-003-0325000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    4NDC:55683-003-0410000 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    5NDC:55683-003-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    6NDC:55683-003-0680 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    7NDC:55683-003-07300 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    8NDC:55683-003-08500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/22/2020
    Labeler - Jiacheng Tech (Zhejiang) Co., Ltd. (554548070)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiacheng Tech (Zhejiang) Co., Ltd.554548070manufacture(55683-003)
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