Label: BIOFREEZE - menthol spray

  • NDC Code(s): 59316-104-25
  • Packager: Performance Health, Inc.
  • 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 09/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol USP 10%

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  • PURPOSE

    Purpose

    Cooling Pain Reliever

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  • INDICATIONS & USAGE

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

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  • WARNINGS

    Warnings: For external use only

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  • STORAGE AND HANDLING

    Flammable: Keep away from excessive heat or open flame

    Contents Under Pressure. Do not Puncture Or Incrinerate.

    Do Not Store At Temperature Above 120 degree Fahrenheit

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  • ASK DOCTOR

    Ask a doctor before use if you have: sensitive skin

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  • WHEN USING


    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 the irritated skin or if excessive irritation develops

    Do not bandage

    Wash hands after use with cool water

    Do not use with heating pad or device

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  • STOP USE

    Stop Use and Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding: Ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: If accidentally ingested get medical help or contact a Poison Control Center immediately.

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  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: Spray on to the affected areas not more than 4 times daily, massage not necessary.

    Children under 12 years of age: Consult physician

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  • STORAGE AND HANDLING

    Other Information: Store in a cool dry place with lid closed tightly

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Arnica Montana Flower Extract, Calendula Oifionalis Flower Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Alcohol Derivat., Mex Paraguariensis Leaf Extract, Isopropyl Myristate, Junipenus Communis Fruis Extract, Water, Cameilia Sinensis Leaf Extract

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  • QUESTIONS

    Questions or Comments? 1-800-246-3733

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  • SPL UNCLASSIFIED SECTION

    No Animal Testing

    Manufactured in the U.S.A.

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  • PRINCIPAL DISPLAY PANEL

    for arthritis, back pain, sore muscles and joints

    BIOFREEZE (R)

    COLD THERAPY PAIN RELIEF

    SOOTHING MENTHOL

    VANISHING SCENT

    PARABEN-FREE

    4 fl oz / 118 mL

    Formulated For Authorized Distribution Through Hands-On Health Professionals For The Patients, Clients and Athletes Under Their Care

    APPLY FROM ANY ANGLE

    EVEN SPRAYS UPSIDE DOWN

    NO NSAID's, IBUPROFEN, ASPIRIN OR SALICYLATE

    (C) 2012 Performance Health, LLC
    1245 Home Avenue
    Akron, OH 44310
    www.biofreeze.com

    panel for biofreeze


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  • INGREDIENTS AND APPEARANCE
    BIOFREEZE  
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59316-104
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 10 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ARNICA MONTANA FLOWER  
    CALENDULA OFFICINALIS FLOWER  
    DIMETHYL SULFONE  
    ECHINACEA ANGUSTIFOLIA  
    ISOPROPYL MYRISTATE  
    JUNIPER BERRY  
    WATER  
    GREEN TEA LEAF  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59316-104-25 118 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 01/15/2013
    Labeler - Performance Health, Inc. (794324061)
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