Label: JIKIMI PATCH- anti-bacterial patch patch

  • 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 5, 2020

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  • Active Ingredient(s)

    Ethyl alcohol 7% w/w………………………...………. Antimicrobial

    Levomenthol 3% w/w………………………...………. Antifungal

    Eucalyptus oil 20% w/w…………………………...…. Antimicrobial

  • Purpose

    To help reduce bacteria.

  • Use

    Apply to affected area as topical aromatic diffusion.

  • Warnings

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

  • Do not use

    • Do not use if you are allergic to any ingredients of this product.
    • Do not use in children under 6 and pregnant or breast-feeding.
  • WHEN USING

    When using this product use only as directed. Use within 2 days after removing the film. Avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts. It happen headache. Conditions worsen.

  • 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

    Remove patch from film.
    Apply to affected area as topical aromatic diffusion not more than 3 to 4 times daily.

    Remove patch at most 24-36 hours application.

  • Other information

    • Store at room temperature between 1-30oC (33.8-86oF).
    • Avoid storing product in direct sunlight.
    • Protect product from excessive moisture.

  • Inactive ingredients

    Extract of fenugreek, Patchouli oil, Thyme oil.

  • Package Label - Principal Display Panel

    Jikimi Ptach 4 piece

  • INGREDIENTS AND APPEARANCE
    JIKIMI PATCH 
    anti-bacterial patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76614-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.03 
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.07 
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.2 
    Inactive Ingredients
    Ingredient NameStrength
    FENUGREEK SEED OIL (UNII: 50LM4E7MG3)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    THYME OIL (UNII: 2UK410MY6B)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76614-100-104 in 1 PACKAGE; Type 0: Not a Combination Product05/01/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2020
    Labeler - BM Pharmaceutical Co., Ltd. (694470190)
    Registrant - BM Pharmaceutical Co., Ltd. (694470190)
    Establishment
    NameAddressID/FEIBusiness Operations
    BM Pharmaceutical Co., Ltd.694470190manufacture(76614-100)