Medistik Cooling Roll-on
FDA Label NDC 77108-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medistik Inc for the product Medistik Cooling Roll-on (NDC 77108-103). 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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
  • cramps

Warnings

When using this product

  • use only as directed
  • avoid getting into the eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin

    • Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation or redness occurs

      • If pregnant or breast-feeding, ask a health professional before use.

Directions

  • For use on adults and children over 12 years of age and older: Apply product on affected area, not more than 4 times daily
  • children under 12 years of age: ask a doctor

Inactive Ingredients

Denatured alcohol, Water, Peppermint oil, Glycerin, Polyacrylate Crosspolymer-6, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

Otc - Keep Out Of Reach Of Children

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

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