Active Ingredient
Menthol 4.0% w/w ...... Purpose: Topical Analgesic
Lanlijen Menthol Pain Relief
FDA Label NDC 83050-231
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 83050-231). 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 conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur
Otc - Ask Doctor
Ask a doctor before use if you have Sensitive Skin
Stop use and ask a doctor if conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur
Otc - Stop Use
Stop use and ask a doctor if conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur
When Using This Product
Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with other creams, sprays, ointments, or liniments • Do not use with heating pad or device • Store in a cool dry place • Do not bandage
Otc - Do Not Use
• Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with other creams, sprays, ointments, or liniments • 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, Rub a thin film over affected areas not more 4 times daily; massage not necessary
Children under 12 years of age, Consult physician
Otc - Ask Doctor/Pharmacist
Children under 12 years of age, Consult physician
Inactive Ingredients
Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Boswellia Carterii Resin Extract, Water, Alcohol, llex Paraguariensis Leaf Extract, Triethanolamine, Carbomer, Camphor, Glycerin, Silica, Isopropyl Myristate, Vitamin E, FD&C Blue 1, FD&C Yellow 5
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
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