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  5. Label Information: Medfreeze Naturally Cool Pain Relief

FDA Label for Medfreeze Naturally Cool Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. INSTRUCTIONS
    11. OTHER INFORMATION
    12. INGREDIENTS
    13. QUESTIONS?
    14. PACKAGE LABELLING:

Medfreeze Naturally Cool Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Medko Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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