Label: CYGZYME PLUS- peracetic acid liquid

  • NDC Code(s): 81803-050-01, 81803-050-02
  • Packager: Valley Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2024

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  • ACTIVE INGREDIENT

    Peracetic acid 0.05%

  • INACTIVE INGREDIENTS

    Water, Lauramine oxide, Sodium bicarbonate, Sodium acetate, anhydrous, Subtilisins, Cellulase, Rizolipase, alpha Amylase, Brilliant Blue, Alcohols, C12-14, ethoxylated, propoxylated, Sodium sesquicarbonate

  • PURPOSE

    Antifungal

  • WARNINGS

    ■ For external use only
    ■ Do not use on the human body
    ■ Avoid contact with eyes.
    ■ Discontinue use if signs of irritation or rashes appear.
    ■ Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Uses

    Helps prevent sterilant

  • Directions

    ■ Rinse thoroughly for more than 5 minutes. Rinse for more than 15 seconds with sterile purified water flowing out after soaking.
    ■ After the disinfection of the medical instrument is completed, confirm the persistence.
    ■ Excess water may be used depending on the purpose of use.

  • QUESTIONS

    +82 02 1566 2723

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CYGZYME PLUS 
    peracetic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81803-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Lauramine oxide (UNII: 4F6FC4MI8W)  
    Sodium bicarbonate (UNII: 8MDF5V39QO)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81803-050-021 in 1 CARTON02/01/2024
    1NDC:81803-050-014000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2024
    Labeler - Valley Inc. (695095445)
    Registrant - Valley Inc. (695095445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Valley Inc.695095445manufacture(81803-050)
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