4% Menthol Pain Relief Gel
FDA Label NDC 52000-439
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 4% Menthol Pain Relief (NDC 52000-439). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 4%
Purpose
Pain Relief Gel
Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame
When using this product • use only as directed • avoid contact with the eyes or on mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin or if excessive irritation develops • do not bandage tightly or use with heating pad or device
Stop use and ask a doctor if • you experience pain, swelling or blistering of the skin • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years of age and older: rub a thin film over affected area not more than3 to 4 times daily • children under 12 years of age: consult a physician • wash hands after use with cool water
Other Information
Store at room temperature • Protect from direct sunlight.
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Arctium Lappa Extract, Arnica Montana Flower Extract, Aminomethyl Propanol, Boswellia Serrata Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue NO.1, FD&C Yellow No.5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water.
Packaging
4% Menthol Pain Relief (52000439 1)
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