Active Ingredient
Menthol 4% ...... Purpose: Topical analgesic
Menthol Overnight Pain Relief Gel-patch
FDA Label NDC 83602-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. for the product Menthol Overnight Pain Relief Gel-patch (NDC 83602-123). 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, do not use, 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
Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.
Warnings
For external use only
Do Not Use
■ on wounds or damaged skin
■ with a heating pad or device
■ with other ointments, creams, sprays, or liniments
■ if you are allergic to any ingredients of this product
When Using This Product
■ use only as directed
■ avoid contact with the eyes, mucous membranes or rashes
■ do not bandage tightly
Stop Use And Ask A Doctor If
■ skin reactions such as redness, swelling, blistering or other discomfort occur
■ symptoms persist for more than 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed accidentally, get medical help or contact with Poison Control Center immediately.
Directions
Adult and Children above 12 years old:
■ Clean and dry the affected area.
■ Tear off the protective film and apply the exposed part of the patch to the affected area.
■ Carefully remove remaining film while pressing the patch firmly on the skin.
■ Remove patch from the skin after at most 8-hour application.
Children under age of 12: Consult a doctor
Inactive Ingredients
Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Essential Oil, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium Dioxide, Water
Questions Or Comments:
Package Label. Principal Display Panel
01 (123 01)
15 (123 15)
* Please review the disclaimer below.
