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Arctic Relief

Stratus Pharmaceuticals, Inc

ARTIC RELIEF PAIN RELIEVING GEL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS

Active ingredient

Purpose

Active Ingredients Purpose
Natural Menthol USP 3.5% Cooling Pain Reliever
Camphor 0.2% Topical Analgesic

Inactive Ingredients

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

Arctic Relief Uses

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

  • arthritis
  • backache
  • strains
  • sprains.

Warnings

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have sensitive skin.

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.

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

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.

Questions or Comments?

Call Customer Service at 800-442-7882

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

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Box

ARTIC RELIEF
PAIN RELIEVING GEL

NDC 58980-615-40

Net WT. 4 oz. / 113.4 grams

•GREASELESS •STAINLESS •VANISHING SCENT

STRATUS
PHARMACEUTICALS

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

Arctic Relief

Arctic Relief

Menthol and Camphor (Synthetic) GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58980-615
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 3.969 g
CAMPHOR (SYNTHETIC) 0.2268 g

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
METHYLPARABEN
SILICON DIOXIDE
TROLAMINE
water

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113.4 in 1 TUBE
2 NDC:58980-615-40 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-01


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Be sure to consult your doctor before taking any medication!
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