Stopain Clinical Gel
FDA Label NDC 63936-9750

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 (NDC 63936-9750). 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 ingredient, purpose, uses, warnings, keep out of reach of children., directions, inactive ingredients, package labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Menthol 10.0%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

​For external use only. ​Avoid contact with eyes.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

​Adults and children over 12 years:

  • apply directly onto affected area without the need to bandage
  • repeat if necessary, but do not apply more than 4 times daily.
  • ​Children 12 years or younger: ask a doctor.​​

Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP)

Package Labeling

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