The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Extra Large Cool And Heat Patch (NDC 0363-9905). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, keep out of reach of children, indications & usage, warnings, dosage & administration, purpose, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic
dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid,polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid,titanium dioxide, water
Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.
For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.
For External Use Only.
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.
Topical Analgesic
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.
■ 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.
ask a health professional before use.
* Please review the disclaimer below.
