Active Ingredients And Purpose
Active Ingredient
Menthol 4%
Purpose
cooling pain relief
Polar ® Frost Cold Gel
- Manufacturer
- Mettler Electronics Corp. | Niva Medical Oy
- Effective date
- 2014-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:39:19
Key Label Information#
Uses
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
Warnings
For external use only
Directions And Dosage
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.
Other Label Information
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 M ETTLER E LECTRONICS ® corp. 150 ml - 5 oz.
Label Images#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 415974 | menthol 4 % Topical Gel | PSN | 1 |
| 1089083 | POLAR FROST 4 % Topical Gel | PSN | 1 |
| 1089083 | menthol 0.04 MG/MG Topical Gel [Polar Frost] | SBD | 1 |
| 415974 | menthol 0.04 MG/MG Topical Gel | SCD | 1 |
| 415974 | menthol 4 % Topical Gel | SY | 1 |
| 1089083 | Polar Frost 0.04 MG/MG Topical Gel | SY | 1 |
| 1089083 | Polar Frost 4 % Topical Gel | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67138-533-05 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a4f-60a7-e053-dbdaa90a05bd | Polar ® Frost Cold Gel |
| 67138-533-15 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a4f-60a7-e053-dbdaa90a05bd | Polar ® Frost Cold Gel |
| 67138-533-50 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a4f-60a7-e053-dbdaa90a05bd | Polar ® Frost Cold Gel |
| 67138-533-64 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a4f-60a7-e053-dbdaa90a05bd | Polar ® Frost Cold Gel |
| 67138-533-75 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4a4f-60a7-e053-dbdaa90a05bd | Polar ® Frost Cold Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67138-533-05 | Polar Frost Cold | 5.43 mL in 1 POUCH | GEL | 5.43 | 1 | |
| 67138-533-15 | Polar Frost Cold | 150 mL in 1 TUBE | GEL | 150 | 1 | |
| 67138-533-50 | Polar Frost Cold | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 1 | |
| 67138-533-64 | Polar Frost Cold | 3785 mL in 1 CANISTER | GEL | 3785 | 1 | |
| 67138-533-75 | Polar Frost Cold | 75 mL in 1 BOTTLE, WITH APPLICATOR | GEL | 75 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67138-533-15 | ML - Milliliter | 67138-533 | cbce290f-a45a-47e3-80bd-c4ef3f5682d7 | 1 | 2014-06-03 |
| 67138-533-75 | ML - Milliliter | 67138-533 | 52bdac84-ce8a-481a-934e-4177a44268f0 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| Aloe Vera Leaf | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| Eucalyptus Oil | INACTIVE INGREDIENT | 2R04ONI662 | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
- Polar Frost Cold
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67138-533 | 67138-533-15, 67138-533-75, 67138-533-50, 67138-533-05, 67138-533-64 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
| Water | 059QF0KO0R | IACT |
| Alcohol | 3K9958V90M | IACT |
| Eucalyptus Oil | 2R04ONI662 | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Aloe Vera Leaf | ZY81Z83H0X | IACT |
| Silicon Dioxide | ETJ7Z6XBU4 | IACT |
| Trolamine | 9O3K93S3TK | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) | 4Q93RCW27E | IACT |
Complete SPL Sections#
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
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 M ETTLER E LECTRONICS ® corp. 150 ml - 5 oz.