Label: PERFORM - menthol spray 

  • Label RSS
  • NDC Code(s): 59316-109-27, 59316-109-29
  • Packager: Performance Health LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 02/14

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

  • Active Ingredients

    Menthol USP   10.4% 

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  • Purpose

    Cooling Pain Relief

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  • Uses:

    Soothing On-The-Go temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis.

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  • Warnings:

    For external use only.

    Flammable:

    Keep away from excessive heat or open flame.

    Ask a Doctor Before Using This Product If You: Have sensitive skin, are pregnant or are breastfeeding.

    When Using This Product:

    • Avoid contact with eyes or mucous membranes
    • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
    • Do not bandage or use with a heating pad or device, ointments, creams, sprays, liniments

    Stop Use and Ask a Doctor If:

    Condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

    Keep Out of Reach of Children:

    If ingested, get medical help. Contact Poison Control Center immediately.

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  • Directions:

    • Adults / Children 12 years and older:  Apply on to affected area up to 4 times daily
    • Children under 12 years of age:  Consult a physician
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  • Other Information:

    Store in a cool, dry place out of direct sunlight.

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  • Inactive Ingredients:

    Arnica Extract, Eucalyptus Oil, Ilex Paraguariensis Extract, Lavender Oil, Lime Oil, Natural Camphor USP, Nutmeg Oil, Orange Oil, Peppermint Oil, Pine Oil, Polysorbate 20, SD Alcohol 39-C, Thyme Oil, Purified Water, White Tea Extract

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  • Questions or Comments?

    1-800-755-2584

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  • Representative Labeling
  • INGREDIENTS AND APPEARANCE
    PERFORM 
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59316-109
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 104 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ARNICA MONTANA  
    EUCALYPTUS OIL  
    ILEX PARAGUARIENSIS LEAF  
    LAVENDER OIL  
    LIME OIL  
    CAMPHOR (SYNTHETIC)  
    NUTMEG OIL  
    ORANGE OIL  
    PEPPERMINT OIL  
    WHITE PINE OIL  
    POLYSORBATE 20  
    THYME OIL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59316-109-27 10 in 1 BOX
    1 1 mL in 1 PATCH
    2 NDC:59316-109-29 118 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/10/2013
    Labeler - Performance Health LLC (794324061)
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Services LLC 557434805 manufacture(59316-109)
    Establishment
    Name Address ID/FEI Business Operations
    Tapemark Company 006154595 manufacture(59316-109)
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