Label: LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH- 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 03/14

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

    Temporarily relieves minor pain associated with:

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

    Warnings

    For external use only

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  • PREGNANCY OR BREAST FEEDING

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

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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 Center right away.

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  • INDICATIONS & USAGE

    Directions

    • adults and children 12 years old
    • peel off protective backing and apply sticky side to affected area
    • 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 85°F (30°C)
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  • INACTIVE INGREDIENT

    Inactive ingredients

    1,3-butylene glycol, aloe vera (powder), dibutylhydroxytoluene, disdoium edate, d-sorbitol solution, gelatin, glycerine, kaolin, light liquid paraffin, magnesium aluminum hydrate, metacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium oxide, tocopherol acetate

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    CARDINAL HEALTH

    DUBLIN, OHIO 43017 USA

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  • INGREDIENTS AND APPEARANCE
    LEADER EXTRA STRENGTH MEDICATED PAIN RELIEF PATCH 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49781-083
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    1,3-BUTYLENE GLYCOL  
    ALOE VERA FLOWER  
    EDETATE DISODIUM  
    GELATIN  
    GLYCERIN  
    KAOLIN  
    PARAFFIN  
    ALUMINUM HYDROXIDE  
    POLYSORBATE 80  
    WATER  
    SORBITAN MONOOLEATE  
    TARTARIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49781-083-70 1 in 1 BOX
    1 1 g in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/25/2014
    Labeler - Cardinal Health (097537435)
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