Medistik Dual
FDA Label NDC 50231-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natureteq Inc. for the product Medistik Dual (NDC 50231-211). 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, directions, inactive ingredients, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Menthol 15%

Methyl Salicylate 30%

Eucaluptus Oil 1%

Purpose

Topical Analgesic

Uses

MEDISTIK™ DUAL provides temporary soothing relief of sore muscles associated with strains and sprains, backaches, lumbago, pain of tendons and/or ligaments as well as arthritic or rheumatic pain

Warnings

For external use only. The application of external heat may cause skin irritation or burn. Avoid contact with eyes and broken skin. Do not bandage. DO NOT USE IF ALLERGIC TO SALICYLATES OR IF TAKING ANTICOAGULANT MEDICATIONS. Stop use and consult a physician if condition worsens, rash or irritation develops, or if symptoms persist for more than 7 days or clear up and recur in a few days.

Directions

For use on adults and children over 12 years of age. Apply generously to the affected area using hands-free applicator. Use 3 to 4 times per day as required. A stinging or burning sensation will be experienced during the first few minutes as the formula begins working. For arthritis or muscle pain of the hands, retain for at least 10 minutes then wash hands.

Inactive Ingredients

Paraffin Wax, Hydrogenated Castor Oil, White Petrolatum, Oleic Acid 700, BHT

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.Principal Display Panel

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