FDA label ccd725b8-1d98-4864-9429-b27d8498e7fe

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
10d39efd-f61e-46df-bd70-26d2ad80a703
SPL ID
ccd725b8-1d98-4864-9429-b27d8498e7fe
Version
1
Effective date
2010-06-10
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:49

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.