The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Cold Therapy Pain Relief (NDC 71101-949). 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, indications & usage, warnings, when using this product, stop use and ask a doctor, 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.
Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic
Topical analgesic
For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.
For External Use Only.
When using this product
■ Use only as directed
■ Rare cases of serious burns have been reported with products of this type
■Don't bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes
■ Don't apply to wounds or damaged skin
■ Do not use at the same time as other topical analgesics.
If condition worsens ■ If redness is present ■ If irritation develops
■ If symptoms persist for more than 7 days or clear up and occur again within a few days.
■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.
ask a health professional before use.
Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician
Store at room temperature, not to exceed 86°F (30°C).
aloe vera extract, arnica montana extract, boswellia carterii resin
extract, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin,
green tea extract, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol,
polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium
dioxide, water
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