Label: ANTIBACTERIAL PVC FILM- copper film

  • 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 June 27, 2020

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

  • ACTIVE INGREDIENT

    copper

  • INACTIVE INGREDIENT

    Polyvinylchloride, Impact Modifier, stabilizer, etc

  • PURPOSE

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    apply proper amount where needed

  • WARNINGS

    For external use only

    When using this product

    ■ if following abnormal symptoms persist, discontinue use

    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    ■ Stop immediately and consult a doctor if you experience

    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

    2) Skin Irritation

    3) Following Instructions when using medication

    (1) For external use only (Do not use internally)

    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

    ■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

    It is not recommended to use this one areas that have been medically treated with a cast or bandage.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL PVC FILM 
    copper film
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79234-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79234-0002-11 g in 1 PACKAGE; Type 0: Not a Combination Product06/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/27/2020
    Labeler - DH Investment Co Ltd (694798202)
    Registrant - DH Investment Co Ltd (694798202)
    Establishment
    NameAddressID/FEIBusiness Operations
    DH Investment Co Ltd694798202manufacture(79234-0002)