FDA Label for Thera Care Cold Hot Medicated Patch
View Indications, Usage & Precautions
Thera Care Cold Hot Medicated 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
Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic
Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves minor aches and pains of muscles and joints: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ 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 a 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 Ask A Doctor
If condition worsens ■ redness is present ■ If irritation develops ■symptoms persist for more than 7 days or clear up and occur again within a few days.■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If Pregnant Or Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
Do not use in infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away
Dosage & Administration
Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.
Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. 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 86F (30C)
Inactive Ingredient
Acrylates Copolymer, Alcohol, Carboxymethylcellulose sodium, Edetate Disodium, Dihydroxyaluminium amino acetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Polyvinyl alcohol, Propylparaben, PVP, Sodium Polyacrylate, Sorbitan oleate, Sorbitol, Tartaric Acid, Titanium Dioxide Water
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