ARCTIC RELIEF PAIN RELIEVING GEL 5%

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Natural Menthol USP 5%

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 - 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.

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.

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. Protect from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Boswellia Extract, Calendula Officinalis Extract, Camphor, Carbomer, Green Tea Leaf Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalisis, Methylparaben, Purified Water, Silicon Dioxide and Triethanolamine.

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 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58980-618-40
Net WT. 4 oz. / 113.4 g

STRATUS
PHARMACEUTICALS INC

ARCTIC RELIEF
PAIN RELIEVING GEL

• GREASELESS • STAINLESS • VANISHING SCENT

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

DailyMed Billing Units#

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

• ARCTIC RELIEF PAIN RELIEVING
• MENTHOL, UNSPECIFIED FORM
• CAMPHOR (SYNTHETIC)
• CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
• ILEX PARAGUARIENSIS LEAF
• ISOPROPYL ALCOHOL
• ALOE VERA LEAF
• ARCTIUM LAPPA ROOT
• BOSWELLIA SERRATA WHOLE
• CALENDULA OFFICINALIS FLOWER
• GREEN TEA LEAF
• METHYLPARABEN
• WATER
• SILICON DIOXIDE
• TROLAMINE
• MELISSA OFFICINALIS WHOLE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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.