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  5. Label Information: Arctic Relief

FDA Label for Arctic Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. INACTIVE INGREDIENTS
    5. USES
    6. WARNINGS
    7. OTC - ASK DOCTOR
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 113.4 GRAM TUBE BOX

Arctic Relief Product Label

The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACTS

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186


Active Ingredient



Natural Menthol USP 3.5%


Purpose



Cooling Pain Reliever


Inactive Ingredients



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


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.


Otc - Ask Doctor



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.


Otc - Keep Out Of Reach Of Children



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


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

PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box - arctic 01

PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box - arctic 01


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