Label: BACTERIA ZERO PREMIUM- peracetic acid liquid

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

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Drug Label Information

Updated August 23, 2020

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  • Active ingredient

    Peracetic acid 0.01%

  • Purpose

    Antiseptic

  • USE

    Fruits, Vegetables, Meat Sterilization(Food Additives), General Object surface Sterilization Sanitizer to help reduce bacteria that potentially can disease.

  • WARNINGS

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

    Check the indications before use.

    Do not inhale the contents that are sprayed or sprayed directly on a person.

  • When using this product

    keep away from 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.

  • DIRECTIONS

    - If the original solution is sprayed on a contaminated place, wipe it with a dry cloth or if it is naturally dried, harmful bacteria are immediately sterilized.

    - Supervise children under 6 years of age when using this product to avoid swallowing.

  • OTHER INFORMATION

    - Store between 1~30℃(33.8~86℉)

    - Avoid freezing(-5℃) and excessive heat above 35℃(86℉)

  • INACTIVE INGREDIENTS

    acetic acid, hydrogen peroxide, Phosphonic acid, purified water USP

  • Package Label

    60ml NDC: 80138-201-01 Label

    100ml NDC: 80138-201-02 Label

    500ml NDC: 80138-201-03 Label

  • INGREDIENTS AND APPEARANCE
    BACTERIA ZERO PREMIUM 
    peracetic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80138-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    PHOSPHOROUS ACID (UNII: 35V6A8JW8E)  
    WATER (UNII: 059QF0KO0R) 99.939 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80138-201-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
    2NDC:80138-201-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
    3NDC:80138-201-03500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2020
    Labeler - KUMSUNG ENC CO., LTD (688082226)
    Registrant - KUMSUNG ENC CO., LTD (688082226)
    Establishment
    NameAddressID/FEIBusiness Operations
    KUMSUNG ENC CO., LTD688082226manufacture(80138-201)
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