FDA Label for Healthwise Medicated Cold Hot 5% Patch
View Indications, Usage & Precautions
Healthwise Medicated Cold Hot 5% 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
Inactive Ingredient
carboxymethylcellulose sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, Mineral Oil, Petrolatum, Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol
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
Indications & Usage
Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps
Warnings
For External Use Only.
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.
Purpose
Topical Analgesic
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 injury, such a s pain, swelling, or blistering where the product was applied.
If Pregnant Or Breastfeeding
ask a health professional before use.
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