Active Ingredient
Menthol 5%
Signature Care Medicated Cold And Hot Patch
FDA Label NDC 21130-987
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care Medicated Cold And Hot Patch (NDC 21130-987). 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, purpose, use, warning, when using this product, stop use and consult a doctor if, if pregnant or breastfeeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Use
For temporary relief of minor muscle and joint pain
Warning
For external use only
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 Consult A Doctor If
■ 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
Keep Out Of Reach Of Children
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.
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.
Directions
Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use.
Reseal pouch after opening. Children under 12 years of age: consult a physician.
Other Information
Store at room temperature, no to exceed 86F (30C)
Inactive Ingredients
Inactive ingredients
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
Questions
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