FDA Label for Headon Ultimate Relief
View Indications, Usage & Precautions
Headon Ultimate Relief Product Label
The following document was submitted to the FDA by the labeler of this product American Health Distributions Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| 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
Otc - Do Not Use
Do not use if you are allergic or hypersensitive to any ingredient in this product, have sensitive skin or any skin disease.
Otc - Ask Doctor
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
Otc - When Using
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.
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
- 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
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
* Please review the disclaimer below.