Active Ingredient
Menthol 5.0%
Menthol Pain Relief Gel-patch
FDA Label NDC 73557-131
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. for the product Menthol Pain Relief Gel-patch (NDC 73557-131). 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, uses:, warnings, ask a doctor before use if you have:, when using this product:, stop use and ask a doctor if:, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses:
Temporary relief from minor aches and pains of sore muscles and joints
associated with: · arthrits · backache · strains · sprains
Warnings
For external use only
Ask A Doctor Before 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 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 direct sunlight
Stop Use And Ask A Doctor If:
Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
If Pregnant Or Breast-Feeding:
Ask a health professional before use
Keep Out Of Reach Of Children:
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions
· Adult and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove 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
Inactive 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, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water
Questions Or Comments:
1 646-223-0128 · [email protected]
Storage And Handling
· Store in a cool dry place away from direct sunlight
Package Label.Principal Display Panel
Container Label (131 01)
Package Label (131 15)
* Please review the disclaimer below.
