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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
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 table
Package NDC	Product	Description	Form	Quantity	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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67138-533	POLAR FROST COLD (MENTHOL) GEL [METTLER ELECTRONICS CORP.]	1	Legacy NDC, 5 package rows	20140520_35fe8a89-e89a-4e1e-bc89-a445e7bc0d44.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
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 table
Ingredient	Type	UNII	SPL version
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#

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

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

Polar Frost Cold
Menthol
Water
Alcohol
Eucalyptus Oil
Propylene Glycol
Aloe Vera Leaf
Silicon Dioxide
Trolamine
Methylparaben
Propylparaben
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67138-533	67138-533-15, 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
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

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 6 of 7 · 368 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4974 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / TOPICAL	2.6 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	EMULSION / TOPICAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
86239ca0-709d-45e4-97b1-c185dc945efb			35fe8a89-e89a-4e1e-bc89-a445e7bc0d44	2014-05-16	Warnings	Exact 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.