Medistik Professional Ice Therapy
FDA Label NDC 50231-421

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 Professional Ice Therapy (NDC 50231-421). 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.

Label Section Quick Index

Active Ingredients

Menthol 10%

Camphor 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of sore muscles and joints associated with

  • strains and sprains
  • backaches
  • lumbago
  • pain of tendons and/or ligaments
  • arthritic or rheumatic pain

Warnings

For external use only. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

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. Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Rashes and/or burning discomfort, and hypersensitivity such as allergy have been known to occur; in which case, discontinue use.

Directions

For use on adults and children over 12 years of age.

Apply to affected area(s) 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

Denatured alcohol, Water, Peppermint oil, Glycerin, Acrylates copolymer, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

Otc - Keep Out Of Reach Of Children

Cautions: Keep out of reach of children. If overdose or accidental ingestion occurs, call a Poison Control Center immediately.

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