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  5. Label Information: Polar Frost Cold

FDA Label for Polar Frost Cold

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. OTC - STOP USE
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL - 150 ML TUBE LABEL

Polar Frost Cold Product Label

The following document was submitted to the FDA by the labeler of this product Mettler Electronics Corp.. 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.

Other



Drug Facts


Active Ingredient



Menthol 4%


Purpose



cooling pain relief


Uses



Provides cooling pain relief of minor aches and pains of muscles and joints associated with simple back-ache, arthritis, strains, bruises and sprains.


Warnings



For external use only


Otc - Do Not Use



Do not use on wounds or damaged skin


When Using This Product



  • avoid contact with eyes
  • avoid contact with mucous membranes
  • do not bandage

Otc - Stop Use



  • If rash or irritation occurs, discontinue use.
  • The application of external heat, such as an electric heating pad, may result in excessive skin irritation or skin burn.
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children.

Directions



  • Adults and children 2 years of age and older:
  • Apply a thin layer to the affected area.
  • Make a second application in 5 minutes.
  • Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Do not use, consult a doctor.

Inactive Ingredients



Water, Alcohol, Eucalyptus Globulus Leaf Oil, Carbomer, Aloe Barbadensis Extract, Propylene Glycol, Triethanolamine, Methylparaben, Silica, Propylparaben, Cl 42090 (FD&C Blue No. 1)


Principal Display Panel - 150 Ml Tube Label



With Aloe Vera

POLAR®
FROST

Pain Relieving Gel

Cold Gel

METTLER ELECTRONICS®
corp.

150 ml - 5 oz.

Principal Display Panel - 150 ml Tube Label - polar frost 01

Principal Display Panel - 150 ml Tube Label - polar frost 01


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