FDA Label for Healthwise Cold Therapy Pain Relief Patch
View Indications, Usage & Precautions
Healthwise Cold Therapy Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Veridian Healthcare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Menthol 5%
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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