Label: ARCTIC RELIEF- menthol, unspecified form gel

  • NDC Code(s): 58980-615-40
  • Packager: STRATUS PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated August 9, 2022

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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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

    PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box
  • INGREDIENTS AND APPEARANCE
    ARCTIC RELIEF 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-615
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM3.969 g  in 113.4 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-615-401 in 1 BOX09/15/2017
    1113.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-615)
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