MAGIC HEAL (DIMETHICONE) STICK [PREMIER TRENDS LLC]

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MAGIC HEAL (DIMETHICONE) STICK [PREMIER TRENDS LLC]
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NDC 72168-786-12
Set ID b7acb7d1-63ef-45fd-bddb-59cea1f1ec95
Category HUMAN OTC DRUG LABEL
Packager PREMIER TRENDS LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Drug Facts:

  • Active Ingredients

    Silicone Oil (Dimethicone) 1%

  • Purpose

    Skin Protectant

  • Uses:

    –Helps to soften and moisturize the skin

    –Decrease itching and flaking

    –Prevent dry, rough, scaly, and skin irritation

  • Warnings:

    – For external use only

    – Do not use on:

    ​Deep or puncture wounds, animal bites, serious burns

    When Using This Product avoid contact with eye.

    Stop Use and Ask a Doctor if condition worsens.

  • KEEP OUT OF REACH OF CHILDREN

    – Keep out of reach of children.

  • Directions

    – Apply as needed. Children under 2 years, ask a doctor.

  • Inactive Ingredients:

    Azadirachta Indica (Neem) Seed Oil, Pongamia Glabra (Karanja) Oil, Vitamin E Oil, Cocoa Butter, Bee Wax, Shea Butter, Sunflower Seed Oil, Blend of Essential Oils.

  • SPL UNCLASSIFIED SECTION

    Heel Therapy That Really Works

    Cracked heels vanish like magic

    Formulated in USA   MFG: Premier Trends LLC, Monroe Township, NJ 08831

    CAUTION:

    The application of Magic HeelTM to your feet may increase the chances of a slip and fall. Use extra care when walking on smooth surfaces with bare feet.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    MAGIC HEAL 
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72168-786
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72168-786-121 in 1 BLISTER PACK03/23/201808/31/2021
    157 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/23/201808/31/2021
    Labeler - PREMIER TRENDS LLC (081105865)
    Establishment
    NameAddressID/FEIBusiness Operations
    PREMIER TRENDS LLC081105865manufacture(72168-786)
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