Stopain Migraine Pain Relieving Gel
FDA Label NDC 63936-8700

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 Migraine Pain Relieving (NDC 63936-8700). 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 iif you have, for external use only., avoid contact with eyes., 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-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

migraine pain

migraine pain

migraine pain

migraine pain

Uses

Temporarily relieves head pain associated with migraine.

Warnings

Do not apply to broken or irritated skin

Do not apply to forehead or temples

Ask A Doctor Before Use Iif You Have

never had migraines diadnosed by a health professional

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 health care professional before using this product topically on children 2 to 12 years of age.

Avoid Contact With Eyes.

If gel gets into eyes or on mucus membranes flush with cool water for 1-2 minutes.

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.

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.

Directions

Adults and children over 12 years

  • Remove cap For first application press down several times to prime actuator pump for use
  • After actuator has been primed press and release pump once to dispense gel onto finger tips
  • Apply to one side on back of neck and behind the ear, repeat for the other side, applying a single pump of product for each side
  • For best results, apply as soon as you feel discomfort
  • If after 30 minutes the symptoms still persist, reapply as needed, up to 4 times daily
  • See insert for more details

Inactive Ingredients

Carbopol polymer, ethanol (USP), pentylene glycol, silicone dioxide, triethanolamine, water (USP)

Other

Manufactured for: Troy Healthcare, LLC 130 Lions Drive, Hazleton, PA 18202

800-201-PAIN (7246)

www.stopain.com

* Please review the disclaimer below.