arctic relief

SPL v6

SPL

SPL Set ID d27fbc17-46b7-4d52-ba29-c99b6c63144a

Route

topical

Published

Effective Date 2024-10-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

menthol, unspecified form (3.969 g)

Inactive Ingredients

camphor (synthetic) carbomer homopolymer type c (allyl pentaerythritol crosslinked) fd&c blue no. 1 fd&c yellow no. 5 ilex paraguariensis leaf isopropyl alcohol

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

otc monograph drug active Since 2017-09-15

Purpose

Cooling Pain Reliever

Description

DRUG FACTS

Medication Information

Warnings

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

Uses

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

arthritis
backache
strains
sprains.

Purpose

Cooling Pain Reliever

Directions

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

Store in a cool dry place with cap closed tightly

Inactive Ingredients

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

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you have sensitive skin.

Active Ingredient

Natural Menthol USP 3.5%

Questions Or Comments?

Call Customer Service at 800-442-7882

When Using This Product

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

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

If Pregnant Or Breast Feeding

Ask a health professional before use.

Principal Display Panel 113.4 Gram Tube Box

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

Structured Label Content

Warnings

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

Uses

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

arthritis
backache
strains
sprains.

Purpose

Cooling Pain Reliever

Directions

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

Store in a cool dry place with cap closed tightly

Inactive Ingredients

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

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have sensitive skin.

Active Ingredient

Natural Menthol USP 3.5%

Questions Or Comments? (Questions or Comments?)

Call Customer Service at 800-442-7882

When Using This Product

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 (Stop Use And Ask A Doctor If)

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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Principal Display Panel 113.4 Gram Tube Box (PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box)

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

Advanced Ingredient Data

[{"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "3.969", "strengthDenominator": "113.4", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ILEX PARAGUARIENSIS LEAF", "unii": "1Q953B4O4F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporary relief from minor aches and pains of sore muscles & joints associated with arthritis backache strains sprains.", "42229-5": "DRUG FACTS", "50565-1": "Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.", "50569-3": "Ask a doctor before use if you have sensitive skin.", "Purpose": "Cooling Pain Reliever", "Warnings": "FOR EXTERNAL USE ONLY . Flammable: Keep away from excessive heat or open flame.", "Directions": "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", "Active Ingredient": "Natural Menthol USP 3.5%", "Other Information": "Store in a cool dry place with cap closed tightly", "Inactive Ingredients": "Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified water.", "Questions or Comments?": "Call Customer Service at 800-442-7882", "When Using This Product": "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": "Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.", "If pregnant or breast-feeding": "Ask a health professional before use.", "PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box": "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:10.709630 · Updated: 2026-03-14T23:04:41.766336