FDA Label for Extra Strength Cold-hot Medicated Patches
View Indications, Usage & Precautions
Extra Strength Cold-hot Medicated Patches Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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
CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center 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: 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 4 times daily. Reseal pouch after opening. Discard patch after single use. Children under 12 years of age: consult a physician.
Purpose
Topical Analgesic
When Using This Product
Use only as directed ■ Don’t bandage tightly or use with heating pad
■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.
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.
If Pregnant Or Breastfeeding
ask a health professional before use.
* Please review the disclaimer below.