Label: HANHOO BLEMISHPATCH- mineral oil patch

  • NDC Code(s): 83857-0001-1
  • Packager: New Bio Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 7, 2023

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  • ACTIVE INGREDIENT

    mineral oil

  • PURPOSE

    skin protectant

    for the treatment of acne

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    1. After cleansing, keep your skin clearly.

    2. Carefully remove dots from the film.

    3. Stick the patch to target areas of concern and gently press down on the patch for 15~30 seconds

    4. Leave in place for 6 hours (Use it during the day or night)

  • 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)

  • INACTIVE INGREDIENT

    water

  • DOSAGE & ADMINISTRATION

    For topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HANHOO BLEMISHPATCH 
    mineral oil patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83857-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL4.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83857-0001-15 g in 1 PACKAGE; Type 0: Not a Combination Product12/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/07/2023
    Labeler - New Bio Pharmaceutical Co., Ltd. (557804030)
    Registrant - New Bio Pharmaceutical Co., Ltd. (557804030)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Bio Pharmaceutical Co., Ltd.557804030manufacture(83857-0001)
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