FDA Label for Extra Large Cool And Heat Patch
View Indications, Usage & Precautions
Extra Large Cool And Heat Patch Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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
dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid,polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid,titanium dioxide, water
Keep Out Of Reach Of Children
Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
Indications & Usage
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.
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. Reseal pouch after opening.
Children 12 years or younger: 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
■ Condition worsens ■ Redness is present ■ 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.
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