Polar Frost Cold
FDA Label NDC 67138-533

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mettler Electronics Corp. for the product Polar Frost Cold (NDC 67138-533). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (150 ml Tube Label)

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