NDC 67567-0306 Headon Ultimate Relief

NDC Product Code 67567-0306

NDC CODE: 67567-0306

Proprietary Name: Headon Ultimate Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

NDC Code Structure

  • 67567 - American Health Distributions Inc.

NDC 67567-0306-1

Package Description: 1 CANISTER in 1 CARTON > 1 STICK in 1 CANISTER

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Headon Ultimate Relief with NDC 67567-0306 is a product labeled by American Health Distributions Inc.. The product's dosage form is and is administered via form.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: American Health Distributions Inc.
Labeler Code: 67567
Start Marketing Date: 06-01-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Headon Ultimate Relief Product Label Images

Headon Ultimate Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Purpose

Active IngredientsPurposeIris versicolor (Blue flag) 12X H.P.U.S. 0.2%Pain RelieverBryonia alba (White bryony) 12X H.P.U.S. 0.08%Pain RelieverThe 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 havenever had migraines diagnosed by a health professionala headache that is different from your usual migrainesthe worst headache of your lifeheadaches beginning after or are caused by head injury, exertion, coughing or bendingexperienced your first headaches after the age of 50daily headachesmigraine headaches so severe as to require bed restfever and stiff neck

Otc - When Using

  • When using this productavoid contact with eyes, wounds, mucous membranes, broken or irritated skindo not share this product with anyonedo not apply a heating pad to foreheadirritation 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 ifskin redness or irritation developsan allergic reaction occurs. Seek medical help right away.migraine headache pain worsens or continues for more than 48 hoursnew or unexpected symptoms occurringing 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 capremove clear inner cap by tilting it to the sideapply directly to forehead at first sign of headache or migraineapply generously covering entire forehead surface area as often as necessaryChildren 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

* Please review the disclaimer below.