Active Ingredient(S)
Menthol 4%
Cold Therapy Roll On Gel
FDA Label NDC 69168-483
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Cold Therapy Roll On (NDC 69168-483). 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(s), purpose, use(s), warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, 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
Pain Relieving Gel
Use(S)
Temporarily relieves minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame
When Using This Product
• use only as directed
• avoid contact with mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device
• children 2 years to under 12 years of age: use only under adult supervision
Stop Use And Ask A Doctor If
• you experience pain, swelling or blistering of the skin
• condition worsens, or symptoms persist for more then 7 days or clear up and occur again
within a few days
• arthritic pain persists for more then 10 days, or redness is present, or in
conditions affecting children under 12 years of age
If Pregnant Or Breastfeeding,
ask a health professional before use.
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Shake well before each use.
Adults and children over 2 years:
• rub a thin film over affected area not more than 3 to 4 times daily
• wash hands after use with cool water
children under 2 years of age: ask a doctor
Other Information
Store at 15°C - 30°C (59°F - 86°F).
Inactive Ingredients
blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5
Questions/Comments
Call 1-888-952-0050
(Monday-Friday 9 AM – 5 PM EST)
Principal Display Panel
Cold Therapy Roll on
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