Label: EXTRA STRENGTH PAIN RELIEF THERAPY - menthol patch

  • 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 06/13

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

    Menthol 5%.................................................................Topical analgesic

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  • PURPOSE

    Uses Temporary relieves minor pain associated with:

    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • bruises
    • cramps
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  • WARNINGS

    Warnings For external use only

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  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin
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  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • skin irritation develops
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years of age and older:
    • peel off protective backing and apply sticky side to affected area
    • carefully remove backing from patch
    • should be used up to 8 hours
    • should be used no more than 3 times a day
    • children under 12 years of age:
    • consult a doctor
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  • STORAGE AND HANDLING

    Other information

    • store at room temperature, not to exceed 86°F (30°C)
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  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non woven fabric.

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF THERAPY  
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65923-701
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 750 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALUMINUM HYDROXIDE  
    BUTYLATED HYDROXYTOLUENE  
    EDETATE DISODIUM  
    GELATIN  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    KAOLIN  
    METHYLPARABEN  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    WATER  
    TARTARIC ACID  
    TITANIUM DIOXIDE  
    ALPHA-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65923-701-05 5 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 06/30/2013
    Labeler - United Exchange Corp (840130579)
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