Arctic Relief

Dosage form: gel
Ingredients: Menthol 3.969g in 113.4g, Camphor (Synthetic) 0.2268g in 113.4g
Labeler: Stratus Pharmaceuticals, Inc
NDC Code: 58980-615

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ARTIC RELIEF
PAIN RELIEVING GEL

DRUG FACTS

Active IngredientsPurpose
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

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 
menthol and camphor (synthetic) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-615
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol3.969 g  in 113.4 g
Camphor (Synthetic) (Camphor (Synthetic)) Camphor (Synthetic)0.2268 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58980-615-401 TUBE (TUBE) in 1 BOX
1113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/01/2009
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Establishment
NameAddressID/FEIOperations
Sonar Products, Inc104283945MANUFACTURE(58980-615)

Revised: 10/2011
 
Stratus Pharmaceuticals, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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