4% Menthol Cold Therapy Gel
FDA Label NDC 52000-442
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 Cold Therapy (NDC 52000-442). 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
Topical analgesic
Uses
• for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains • provides cooling pain relief
Warnings
For external use only
When using this product
• avoid contact with eyes • do not apply to wounds or damaged skin
• do not bandage tightly • do not use with heating pads or heating devices
Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable: Keep away from excessive heat or open flame
If pregnant or breastfeeding, 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor
• wash hands after use with cool water
Other Information
• store in a cool dry place away from direct sunlight • store with cap closed tightly
Inactive Ingredients
Arnica Montana Flower Extract, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Arctium Lappa Extract, Butylene Glycol, Boswellia Serrata Resin Extract, Camphor, Carbomer, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, FD&C Blue No.1, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Melissa Officinalis Leaf Extract, Methyl Methacrylate Crosspolymer, Tocopheryl Acetate, Water, Yellow No.5
Packaging
4% Menthol Cold Therapy Gel (52000442 2)
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