Active Ingredients (% By Weight)
Camphor 4%
Menthol 10%
Camphotrol Gel
FDA Label NDC 59088-488
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Camphotrol (NDC 59088-488). 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 ingredients (% by weight), purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Analgesic (pain relief)
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.
Warnings
For external use only
Do Not Use On
■ wounds ■ damaged skin
When Using This Product
■ avoid getting into eyes or mucous membranes ■ do not bandage tightly
Stop Use And Ask A Doctor If
■ excessive irritation of the skin develops ■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily
■ children under the age of 12: do not use, consult a doctor ■ use only as directed
Other Information
■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Powder, Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.
* Please review the disclaimer below.
