Headon
FDA Label NDC 67567-0306

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Health Distributions Inc. for the product Headon (NDC 67567-0306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, use, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
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

Principal Display Panel (5.67 gram canister carton)

Principal Display Panel (5.67 gram canister carton)

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