ARCTIC RELIEF

Manufacturer: STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC
Effective date: 2024-10-31
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:32:54

Label at a glance#

ProductARCTIC RELIEF

Active ingredientMENTHOL, UNSPECIFIED FORM

Label structure11 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles & joints associated with arthritis backache strains sprains.

Dosage and administration

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary. Children under 2 years of age: Consult physician

Storage and handling

Store in a cool dry place with cap closed tightly

Contacts and useful links#

PhoneLabel contact800-442-7882

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Natural Menthol USP 3.5%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified water.

Uses

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles & joints associated with

arthritis
backache
strains
sprains.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have sensitive skin.

When Using This Product

OTC - WHEN USING SECTION

Avoid contact with the eyes or mucous membranes
Do not apply to wounds or damaged skin
Do not use with other ointments, creams, sprays or liniments
Do not apply to irritated skin or if excessive irritation develops
Do not bandage
Wash hands after use with cool water
Do not use with a heating pad or device.

Stop Use And Ask A Doctor If

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
Children under 2 years of age: Consult physician

Other Information

STORAGE AND HANDLING SECTION

Store in a cool dry place with cap closed tightly

Questions or Comments?

OTC - QUESTIONS SECTION

Call Customer Service at 800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arctic Relief
PAIN RELIEVING GEL

NDC 58980-615-40

Net WT. 4 oz. / 113.4 grams

•GREASELESS •STAINLESS •VANISHING SCENT

PENETRATING, LONG-LASTING PAIN RELIEF FROM:
ARTHRITIS, SORE MUSCLES & JOINTS AND BACK PAIN.

STRATUS
PHARMACEUTICALS INC

PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
808955	menthol 3.5 % Topical Gel	PSN	6
808955	menthol 0.035 MG/MG Topical Gel	SCD	6
808955	menthol 3.5 % Topical Gel	SY	6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58980-615-40	ARCTIC RELIEF	113.4 g in 1 TUBE	GEL	113.4		6
58980-615-40	ARCTIC RELIEF	1 in 1 BOX	GEL	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58980-615	ARCTIC RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [STRATUS PHARMACEUTICALS INC]	6	Current NDC, Legacy NDC, 2 package rows	20241102_d27fbc17-46b7-4d52-ba29-c99b6c63144a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-615-40	GM - Gram	58980-615	e44c4e78-2486-4b19-a55b-db3d3ddfc683	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Camphor (Synthetic)	ACTIVE INGREDIENT	5TJD82A1ET	1
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
Camphor (Synthetic)	ACTIVE MOIETY	5TJD82A1ET	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	1
carbomer homopolymer type c	INACTIVE INGREDIENT	4Q93RCW27E	1
FD&C blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C yellow NO. 5	INACTIVE INGREDIENT	I753WB2F1M	1
ilex paraguariensis leaf	INACTIVE INGREDIENT	1Q953B4O4F	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	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 · 8 matching rows.

ARCTIC RELIEF
MENTHOL, UNSPECIFIED FORM
CAMPHOR (SYNTHETIC)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58980-615	58980-615-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
ILEX PARAGUARIENSIS LEAF	1Q953B4O4F	IACT
ISOPROPYL ALCOHOL	ND2M416302	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 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
trolamine	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
carbomer homopolymer type c	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C yellow NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii+route 6 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
isopropyl alcohol	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 12 equally ranked IID candidates
carbomer homopolymer type c	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii+route+dosage form 2 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
ARCTIC RELIEF	MENTHOL, UNSPECIFIED FORM	STRATUS PHARMACEUTICALS INC	d27fbc17-46b7-4d52-ba29-c99b6c63144a	2024-10-31	Warnings	Exact identifier ndc (package): 58980-615-40 ndc (product): 58980-615 ndc11 (package): 58980061540 spl id: db73c60c-1ff8-4b16-a467-6f0b8727f1d6 spl set id: d27fbc17-46b7-4d52-ba29-c99b6c63144a

Reported adverse events (FAERS/openFDA)#

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