POLAR FROST COLD- menthol gel 
Mettler Electronics Corp.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Polar® Frost Cold Gel

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

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 COLD 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67138-533
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67138-533-15150 mL in 1 TUBE
2NDC:67138-533-7575 mL in 1 BOTTLE, WITH APPLICATOR
3NDC:67138-533-50500 mL in 1 BOTTLE, PUMP
4NDC:67138-533-055.43 mL in 1 POUCH
5NDC:67138-533-643785 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/11/2002
Labeler - Mettler Electronics Corp. (008513913)
Establishment
NameAddressID/FEIBusiness Operations
Niva Medical Oy651595779MANUFACTURE(67138-533)

Revised: 5/2014
Document Id: 86239ca0-709d-45e4-97b1-c185dc945efb
Set id: 35fe8a89-e89a-4e1e-bc89-a445e7bc0d44
Version: 1
Effective Time: 20140516
 
Mettler Electronics Corp.