FDA.reportPublic FDA data

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

Label at a glance#

ProductPolar Frost Cold
Active ingredientMenthol
Label structure8 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

cooling pain relief

Uses

INDICATIONS & USAGE SECTION

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 SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on wounds or damaged skin

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • 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 SECTION

  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
1089083POLAR FROST 4 % Topical GelPSN1
1089083menthol 0.04 MG/MG Topical Gel [Polar Frost]SBD1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1
1089083Polar Frost 0.04 MG/MG Topical GelSY1
1089083Polar Frost 4 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67138-533-052019-11-27C16284748780-19855e2a2-4a4f-60a7-e053-dbdaa90a05bdPolar ® Frost Cold Gel
67138-533-152019-11-27C16284748780-19855e2a2-4a4f-60a7-e053-dbdaa90a05bdPolar ® Frost Cold Gel
67138-533-502019-11-27C16284748780-19855e2a2-4a4f-60a7-e053-dbdaa90a05bdPolar ® Frost Cold Gel
67138-533-642019-11-27C16284748780-19855e2a2-4a4f-60a7-e053-dbdaa90a05bdPolar ® Frost Cold Gel
67138-533-752019-11-27C16284748780-19855e2a2-4a4f-60a7-e053-dbdaa90a05bdPolar ® Frost Cold Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67138-533-05Polar Frost Cold5.43 mL in 1 POUCHGEL5.431
67138-533-15Polar Frost Cold150 mL in 1 TUBEGEL1501
67138-533-50Polar Frost Cold500 mL in 1 BOTTLE, PUMPGEL5001
67138-533-64Polar Frost Cold3785 mL in 1 CANISTERGEL37851
67138-533-75Polar Frost Cold75 mL in 1 BOTTLE, WITH APPLICATORGEL751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67138-533POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]1Legacy NDC, 5 package rows20140520_35fe8a89-e89a-4e1e-bc89-a445e7bc0d44.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67138-533-15ML - Milliliter67138-533cbce290f-a45a-47e3-80bd-c4ef3f5682d712014-06-03
67138-533-75ML - Milliliter67138-53352bdac84-ce8a-481a-934e-4177a44268f012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A1
MentholACTIVE MOIETYL7T10EIP3A1
AlcoholINACTIVE INGREDIENT3K9958V90M1
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENT4Q93RCW27E1
Eucalyptus OilINACTIVE INGREDIENT2R04ONI6621
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67138-53367138-533-15, 67138-533-75, 67138-533-50, 67138-533-05, 67138-533-64

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Water059QF0KO0RIACT
Alcohol3K9958V90MIACT
Eucalyptus Oil2R04ONI662IACT
Propylene Glycol6DC9Q167V3IACT
Aloe Vera LeafZY81Z83H0XIACT
Silicon DioxideETJ7Z6XBU4IACT
Trolamine9O3K93S3TKIACT
MethylparabenA2I8C7HI9TIACT
PropylparabenZ8IX2SC1OHIACT
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)4Q93RCW27EIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 7 of 7 · 368 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
86239ca0-709d-45e4-97b1-c185dc945efb35fe8a89-e89a-4e1e-bc89-a445e7bc0d442014-05-16WarningsExact identifier
spl id: 86239ca0-709d-45e4-97b1-c185dc945efb
spl set id: 35fe8a89-e89a-4e1e-bc89-a445e7bc0d44

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.