Active Ingredients (In Each Patch)
Menthol 5%
Menthol 5% Patch
FDA Label NDC 80425-0543
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Menthol 5% (NDC 80425-0543). 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 ingredients (in each patch), uses, purpose, warnings, consult with a doctor or pharmacist before continued use if you have, when using this product, stop use and ask a doctor if, if you are pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporary relief from minor aches and pains of sore muscles and joints
associated with:
- arthrits
- backache
- strains
- sprains
Purpose
External Analgesic
Warnings
For external use only.
Consult With A Doctor Or Pharmacist Before Continued Use If You Have
Sensitive Skin
When Using This Product
- Use only as directed
- Do not bandage tightly or use with heating pad or device
- Avoid contact with the eyes or mucous membranes
- Do not apply to wounds or damaged skin
- Do not use with other ointments,creams,sprays, or liniments
- Do not apply to irritated skin
- Store in a cool, dry place away from sunlight
Stop Use And Ask A Doctor If
Burning discomfort or excessive skin irritation develops, condition wrosens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
If You Are Pregnant Or Breast-Feeding
IF YOU ARE PREGNANT OR BREAST-FEEDING: Consult with physician before use of this product.
Keep Out Of The Reach Of Children
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions:
Adults and Children 12 Years of Age or Over:Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.
Children Under 12 Years of Age:Consult physician.
Other Ingredients
Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water
Questions?
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