ARCTIC RELIEF ROLL ON

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Natural Menthol USP 4.0%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and recur. ▶

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call customer service at 800-442-7882

SPL UNCLASSIFIED SECTION

Distributed by:
Stratus Pharmaceuticals Inc.
12379 SW 130th Street, Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 90 gram Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-617-31

Arctic Relief

PAIN RELIEVING GEL

EASY TO USE
ROLL-ON

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

• GREASELESS
• STAINLESS
• VANISHING SCENT

Net WT. 90 grams

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

• ARCTIC RELIEF ROLL ON
• 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#

Ingredients#

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

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

Source Document#

Source XML

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.

Reported adverse events (FAERS/openFDA)#

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