Medistik
FDA Label NDC 50231-311

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 (NDC 50231-311). 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 otc - active ingredient, otc - purpose, uses, warnings, dosage & administration, inactive ingredient, 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

Otc - Active Ingredient

Active Ingredients

Menthol 15%

Methyl Salicylate 30%

Otc - Purpose

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backaches
  • strains
  • sprains
  • bruises
  • arthritis

Warnings

For external use only.  Do not use other than as directed.

Do not apply

  • to wounds or damaged skin
  • with a heating pad

    • When using this product

    • avoid getting into the eyes or mucous membranes
    • do not bandage tightly

      • Stop use and consult a doctor if

      • condition worsens or symptoms persist for more than 7 days
      • symptoms clear up and occur again within a few days
      • rash or excessive irritation of the skin develops

        • Keep out of the reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

        Allergy Alert:  Do not use if allergic to salicylates or if taking anticoagulant medications.

Dosage & Administration

Directions

  • use only as directed
  • adults and children 12 years of age and older: apply directly to the affected area using hands-free applicator
  • application should be limited to 3 or 4 times daily
  • children under 12 years of age: ask a physician

Inactive Ingredient

Inactive Ingredients

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

Otc - Keep Out Of Reach Of Children

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Package Label.Principal Display Panel

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