Label: ARCTIC RELIEF- menthol and camphor (synthetic) gel

  • NDC Code(s): 58980-615-40
  • Packager: Stratus Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Natural Menthol USP 3.5% Cooling Pain Reliever
    Camphor 0.2% Topical Analgesic
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  • Inactive Ingredients

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

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  • Uses

    Temporary relief from minor aches and pains of sore muscles & joints associated with

    • arthritis
    • backache
    • strains
    • sprains.
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  • 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.

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  • 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.
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  • Other Information

    Store in a cool dry place with cap closed tightly.

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  • Questions or Comments?

    Call Customer Service at 800-442-7882

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc.
    12379 S.W. 130th Street
    Miami, FL 33186

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  • 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.

    Principal Display Panel - 113.4 g Tube Box
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  • INGREDIENTS AND APPEARANCE
    ARCTIC RELIEF 
    menthol and camphor (synthetic) gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58980-615
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (Menthol) Menthol 3.969 g  in 113.4 g
    Camphor (Synthetic) (Camphor (Synthetic)) Camphor (Synthetic) 0.2268 g  in 113.4 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color GREEN Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-615-40 1 in 1 BOX
    1 113.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 10/01/2009
    Labeler - Stratus Pharmaceuticals, Inc (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE(58980-615)
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