Active Ingredient
Menthol 8.0%
Stopain Extra Strength Gel
FDA Label NDC 63936-9506
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 Extra Strength Gel (NDC 63936-9506). 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, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Flammable: Keep away from fire or flame.
When Using This Product
• use only as directed
• do not bandage tightly or use a heating pad
• do not apply to wounds or damaged skin
Stop Use And Ask A Doctor If
• condition worsens, or if 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 develops
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.
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.
Other Information
- Store at room temperature
Inactive Ingredients
acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).
Package Labeling:
Label (Label)
* Please review the disclaimer below.
