Active Ingredients
Methyl salicylate 25%
Methylten 25% Cream
FDA Label NDC 59088-245
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 Methylten 25% (NDC 59088-245). 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, purpose, uses, warnings, otc - keep out of reach of children, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
For external use only
Otc - Keep Out Of Reach Of Children
Keep this and all other drugs out of the reach of children.
When Using This Product
■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or damaged skin
Stop Use And Ask A Doctor If
■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
Directions
■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician.
Other Information
■ Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha Tocopheryl Acetate, Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil, Fragrance.
Methylten™ 25%
Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free: 1
-877-921-7873
Label (Label)
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