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HeadOn (American Health Distributions Inc.)

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STICK 1 CANISTER in 1 CARTON (67567-0306-1) > 1 STICK in 1 CANISTER Label Information

Complete HeadOn Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Iris versicolor (Blue flag) 12X H.P.U.S. 0.2% Pain Reliever
    Bryonia alba (White bryony) 12X H.P.U.S. 0.08% Pain Reliever

    The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


  • Use

    • Temporarily relieves the symptoms of headache and migraine pain

  • Warnings

    For external use only

    Do not use if you are allergic or hypersensitive to any ingredient in this product, have sensitive skin or any skin disease.

    Ask a doctor before use if you have

    • never had migraines diagnosed by a health professional
    • a headache that is different from your usual migraines
    • the worst headache of your life
    • headaches beginning after or are caused by head injury, exertion, coughing or bending
    • experienced your first headaches after the age of 50
    • daily headaches
    • migraine headaches so severe as to require bed rest
    • fever and stiff neck

    When using this product

    • avoid contact with eyes, wounds, mucous membranes, broken or irritated skin
    • do not share this product with anyone
    • do not apply a heating pad to forehead
    • irritation or allergic reaction may occur with some people. Test by applying product to a small area of the forehead and wait 30 minutes. If skin appears normal, proceed with Directions.

    Stop use and ask a doctor if

    • skin redness or irritation develops
    • an allergic reaction occurs. Seek medical help right away.
    • migraine headache pain worsens or continues for more than 48 hours
    • new or unexpected symptoms occur
    • ringing in the ears or loss of hearing occurs

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • Adults and children 12 years and older:
    • remove white outer cap
    • remove clear inner cap by tilting it to the side
    • apply directly to forehead at first sign of headache or migraine
    • apply generously covering entire forehead surface area as often as necessary
    • Children under 12 years of age: ask a doctor

  • Other information

    Store between 15° and 30° C (59° and 86° F).


  • Inactive Ingredients

    diazolidinyl urea, ethyl alcohol, iodopropynyl butylcarbamate, menthyl lactate, propylene glycol, sodium stearate, steareth-21, tetrasodium EDTA, triethanolamine, water


  • SPL UNCLASSIFIED SECTION

    Dist. by Miralus Healthcare
    Cheyenne, WY 82001


  • Questions ?

    call 1-877-373-3436, Weekdays 9AM to 5PM EST or visit us online at www.miralus.com


  • PRINCIPAL DISPLAY PANEL - 5.67 gram canister carton

    NEW

    Apply directly
    to forehead

    HEADON®
    Headache Relief

    ULTIMATE RELIEF

    Headache & Migraine Reliever

    PRINCIPAL DISPLAY PANEL - 5.67 gram canister carton

  • INGREDIENTS AND APPEARANCE
    HEADON  ULTIMATE RELIEF
    iris versicolor root and bryonia alba root stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67567-0306
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root 12 [hp_X]
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 12 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    alcohol (UNII: 3K9958V90M)  
    iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
    menthyl lactate (UNII: 2BF9E65L7I)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium stearate (UNII: QU7E2XA9TG)  
    EDETATE sodium (UNII: MP1J8420LU)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67567-0306-1 1 in 1 CARTON
    1 1 in 1 CANISTER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 06/01/2010
    Labeler - American Health Distributions Inc. (010328220)
    Establishment
    Name Address ID/FEI Business Operations
    CPC Laboratories Inc. 026453260 MANUFACTURE, LABEL, PACK