POLAR FROST COLD- menthol gel

Polar Frost Cold by

Drug Labeling and Warnings

Polar Frost Cold by is a Otc medication manufactured, distributed, or labeled by Mettler Electronics Corp., Niva Medical Oy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Do not use on wounds or damaged skin

When using this product

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

• 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.

• 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.

INGREDIENTS AND APPEARANCE

POLAR FROST COLD 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67138-533
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Eucalyptus Oil (UNII: 2R04ONI662)
Propylene Glycol (UNII: 6DC9Q167V3)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Trolamine (UNII: 9O3K93S3TK)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67138-533-15	150 mL in 1 TUBE
2	NDC: 67138-533-75	75 mL in 1 BOTTLE, WITH APPLICATOR
3	NDC: 67138-533-50	500 mL in 1 BOTTLE, PUMP
4	NDC: 67138-533-05	5.43 mL in 1 POUCH
5	NDC: 67138-533-64	3785 mL in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	11/11/2002

Labeler - Mettler Electronics Corp. (008513913)

Establishment
Name	Address	ID/FEI	Business Operations
Niva Medical Oy		651595779	MANUFACTURE(67138-533)