FDA Label for Theracare 5% Menthol Pain Relief Patch
View Indications, Usage & Precautions
Theracare 5% Menthol 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
Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic
Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis ■ muscle strains ■ muscle sprains ■ bruises ■ cramps
Warnings
For External Use Only.
When Using This Product
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 Ask A Doctor
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 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 on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Dosage & Administration
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. 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
Inactive ingredients
alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water
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