Active Ingredient
Menthol 4% ...... Purpose: Topical Analgesic
Menthol Pain Relief Gel-roll On Gel
FDA Label NDC 83602-333
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 Pain Relief Gel-roll On (NDC 83602-333). 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 ... if, ... ask a doctor if, 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, ankle, 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 ... If
• skin reactions such as redness, swelling, blistering or other discomfort occur
• symptoms persist for more than 7 days
... 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
Adults and children 12 years of age and older:
• Rub a thin film over affected areas not more than 4 times daily;
• Message not necessary
Children under 12 years of age: Consult physician.
Wash hands after use with cool water.
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water
Questions Or Comments:
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