Label: TLCUO PHYTONCIDE- peroxy acetic acid spray

  • 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 April 9, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Peroxy acetic acid 0.26%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Lavenda Essential Oil, Peppermint Essential Oil, Citronella Essential Oil, Phytoncide Essential Oil, Cypress water, Water

  • PURPOSE

    Purpose: SANITIZER, ANTISEPTIC, Deodorant

  • WARNINGS

    Warnings:


    1.Do not use the product on the following areas:
    Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

    2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.

    If symptoms such as rash, itching, edema, and skin irritation occur, please stop using it.
    3.Other precautions
    1) For external use only (do not swallow).

    2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.

    3)Do not use in anal or vaginal areas as they may cause irritation.

    4) Use only for the intended purposes.

    4.Precautions for storage
    1) Keep away from direct sunlight and do not expose the product to heating devices or flame.

    2) Keep out of reach of children and go to the hospital immediately if swallowed.

    3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.

    4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and go to the hospital immediately if swallowed.

  • Uses

    Uses:

    Disinfection of Human’s hands and skin

    TLCUO, made of active peracetic acid,(PAA) is an effective sterilizing agent for bacillus, viruses, bacteria, etc. as well as odor removal for Human Body

  • Directions

    Directions:

    Take an appropriate amount on your hands and rub thoroughly to dry.

    Rub evenly over areas of your hands or feet to dry naturally. For infants, the skin is weak and sensitive, preferably not to be used.

  • PACKAGE LABEL - TLCUO Phytoncide 60mL

    Image of bottle

  • PACKAGE LABEL - TLCUO Phytoncide 500mL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    TLCUO PHYTONCIDE 
    peroxy acetic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74438-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERACETIC ACID (UNII: I6KPI2E1HD) (PERACETIC ACID - UNII:I6KPI2E1HD) PERACETIC ACID0.26 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74438-030-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
    2NDC:74438-030-02500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2020
    Labeler - KTL LTD (694481741)
    Registrant - KTL LTD (694481741)
    Establishment
    NameAddressID/FEIBusiness Operations
    KTL LTD694481741manufacture(74438-030)