Stopain Clinical Migraine And Headache Gel
FDA Label NDC 63936-9700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Troy Manufacturing, Inc. for the product Stopain Clinical Migraine And Headache (NDC 63936-9700). 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 active ingredients, purpose, uses, warnings, ask a doctor before use if, keep out of reach of children., stop use and consult a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mentholum 1X HPUS-60.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

Frontal Headache

Temple/Occiput Pain

Sick Headache

Back of Head Pain

Uses

Temporarily relieves head pain associated with migraine and headache.

Warnings

For external use only. This product should not be used topically on children younger than 2 years of age nor should it be applied on any mucus membranes of any age child or adult. Seek the advice of your healthcare professional before using this product topically on children 2-12 years of age.

Avoid contact with eyes. If gel gets in eyes or on muscus membranes flush with cool water for 1-2 minutes

Ask A Doctor Before Use If

you have never had migraines diagnosed by a health professional

• Do not apply to broken or irritated skin

• Do not apply to forehead or temples

Keep Out Of Reach Of Children.

If swallowed, get medicial help or contact a Poison Control Center.

Stop Use And Consult A Doctor If

• condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

• redness is present • excessive irritation of the skin occurs

If Pregnant Or Breast Feeding

ask a health professional before use.

Directions

• Adults and children over 12 years: Tear open packe • Dispense product onto finger tips • Apply to back of neck and behind each ear until product is absorbed •  Use entire contents of packet • For best results, apply as soon as you feel discomfort • If after 30 minutes the symptoms persist, apply second packet

Inactive Ingredients:

Acrylic acid/vinyl ester copolymer, ethanol (USP), hydroxypropylcellulose, pentylene glycol, triethanolamine, water (USP)

Package Labeling:

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