Medfreeze Naturally Cool Pain Relief Liquid
FDA Label NDC 84443-487

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medko Llc for the product Medfreeze Naturally Cool Pain Relief (NDC 84443-487). 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, do not use, ask a doctor before use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 12%

Purpose

Cooling pain relief

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:  Simple, backache, arthritis, strains, sprains.

Warnings

  • For external use only
  • Flammable 
  • Keep away from excessive heat or open flame 
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)

Do Not Use

  • With heating pad or device 
  • With ointments, creams, sprays or liniments 
  • On wounds, damaged skin or irritated skin

Ask A Doctor Before Use If You

  • Have sensitive skin
  • Are pregnant or breastfeeding

When Using This Product

  • Avoid contact with eyes or mucous membranes 
  • Do not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens 
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days  
  • Irritation develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Instructions

Adults / Children 2 years and older:

  • Spray on the affected area not more than 3 to 4 times daily 
  • Shake well before use

    • Children under 2 years old:Consult a physician.

Other Information

  • Replace cap after use 
  • Store in a cool, dry place

Ingredients

Aqua (deionized water), Calendula officinalis extract, Camellia Sinensis (green tea) extract, Chamomilla Matricaria (chamomile) extract, Citric acid, Echinacea angustifolia extract, Glycerin, Ilex Paraguariensis (Yerba Mate) extract, Berry extract of Juniperus Communis (juniper), Methylsulfonylmethane (MSM), SD-Alcohol 40B.

Questions?

Call 786-956-7146

Package Labelling:

Label.jpg (Label)

Label.jpg (Label)

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