Active Ingredient
Menthol 5%
Healthwise Cold Therapy Pain Relief Patch
FDA Label NDC 71101-950
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Healthwise Cold Therapy Pain Relief Patch (NDC 71101-950). 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, use, warnings, when using this product, stop use and consult a doctor if, if pregnant or breast-feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps
Warnings
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.
Stop Use And Consult A Doctor If
o condition worsens
o redness is present
o irritation develops
o symptoms persist for more than 7 days or clear up and occur again within a few days
o you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast-Feeding
ask a health professional before use.
Directions
Directions
■ Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove back ng starting at a corner. 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. Reseal pouch after opening.
■Children under 12 years of age: consult a physician.
Other Information
Store at room temperature, not to exceed 86'F (30'C).
Inactive Ingredient
aloe vera extract, arnica montana extract, boswellia carterii resin extract, carboxymethylcellulose sodium, ethylhexylglycerin, dihydroxyaluminum aminoacetate, 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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