Asystem Radical Relief Gel Roll-on Gel
FDA Label NDC 52261-4902

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Asystem Radical Relief Gel Roll-on (NDC 52261-4902). 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, otc - purpose, uses:, warnings:, otc - keep out of reach of children, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Menthol - 10% (External Analgesic)
Methyl Salicylate (NSAID) – 15% (External Analgesic)

Otc - Purpose

External Analgesic

Uses:

For temporary relief of the minor aches and pains of muscles and joints associated with backache, muscle ache, strains, sprains, bruises, cramps, arthritis, and inflammation.

Warnings:

For External Use Only

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Do Not Use

Do not use: on wounds or damaged skin, with a heating pad, on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area.

Otc - When Using

Avoid contact with eyes.  If contact occurs, flush throughly with water.

Directions:

Use only as directed.  Apply generously and massage to affected area as needed.  Do not use more than 3 to 4 times per day.  Children under 12 years of age ; ask a doctor before use.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethylpropanol, Arnica Montana Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Glyceryl Stearate/PEG-100 Stearate, Isopropyl Myristate, Magnesium Hydroxide, Maritime Pine, Phenoxyethanol, Polysorbate 80, Tocopherol Acetate, Water

Other Safety Information

Allery Alert:  Do not use if you are allergic to salicylates (including aspritin) without consulting a physician.

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