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ARCTIC RELIEF

Medically reviewed on October 23, 2017

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM 3.969g 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.

ARCTIC RELIEF

DRUG FACTS

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.

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.
Miami, FL 33186

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

ARCTIC RELIEF 
menthol, unspecified form 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, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM3.969 g  in 113.4 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58980-615-401 TUBE in 1 BOX
1113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/15/2017
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIOperations
TARMAC PRODUCTS INC059890491MANUFACTURE(58980-615), LABEL(58980-615), PACK(58980-615)

 
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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