Active Ingredient
Menthol 5.0% w/w ...... Purpose: Topical Analgesic
Lanlijen Menthol Pain Relief
FDA Label NDC 83050-251
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Chaben Medical Healthcare Technology Co.,ltd for the product Lanlijen Menthol Pain Relief (NDC 83050-251). 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, otc - ask doctor, otc - stop use, when using this product, otc - do not use, 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 arthritic, backache, strains and sprains
Warnings
For external use only
Flammable, Keep away from excessive heat or open flame
Ask a doctor before use if you have Sensitive Skin
Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days
Otc - Ask Doctor
Ask a doctor before use if you have Sensitive Skin
Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days
Otc - Stop Use
Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days
When Using This Product
Avoid contact with eyes or mucous membranes • Do not use with other creams, sprays, ointments, or liniments • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with heating pad or device • Store in a cool dry place • Do not bandage • Use only as directed • Wash hands after use with cool water.
Otc - Do Not Use
• Do not use with other creams, sprays, ointments, or liniments • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with heating pad or device
Storage And Handling
• Store in a cool dry place
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
Adults and children 12 years of age and older, 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. Clean and dry afected areas, partially peel back protective film and apply exposed patch to site of pain.
Children under 12 years of age, Consult physician
Otc - Ask Doctor/Pharmacist
Children under 12 years of age, Consult physician
Inactive Ingredients
Aloe barbadensis leaf extract, Arnica montana flower extract, Benzalkonium chloride, Boswellia carterii resin extract, Camellia sinensis leaf extract, Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Lauralkonium chloride, L-Tartaric acid, Mineral oil, Petrolatum, PVP, Polyacrylic acid, Polysorbate 80, Propylene glycol, Sodium polyacrylate, Titanium dioxide, Water
Questions Or Comments
86-513-89072216
E-mail:[email protected]
www.lanlijen.com
Tel:86-513-89072216
Other Safety Information
No Animal Testing, No NSAIDs, lbuprofen, Aspirin or Salicylate
Package Label. Principal Display Panel
Container Package (251 Pack)
Box Labeling (251 Box)
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