Label: ARCTIC RELIEF- menthol, unspecified form gel

  • NDC Code(s): 58980-615-40
  • Packager: STRATUS PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2024

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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 DrugM01709/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-615)
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