Label: WELLPATCH BACKACHE PAIN RELIEF- menthol patch

  • NDC Code(s): 10742-8123-1, 10742-8123-2
  • Packager: The Mentholatum Company
  • 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 05/11

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  • Active ingredient

    Menthol, natural 5%

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  • Purpose

    Menthol, natural - Topical Analgesic

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  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to

    • simple backache
    • arthritis
    • strains
    • sprains
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  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not get into eyes or on mucous membranes
    • do not apply to wounds or to damaged or very sensitive skin
    • do not bandage tightly or cover with any type of wrap except clothing
    • do not use with a heating pad or apply external heat
    • do not use in combination with other external analgesic products

    Stop use and ask a doctor if

    • condition worsens
    • excessive redness, irritation, burning, or discomfort of the skin develops
    • pain persists for more than 7 days
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
    • children under 12 years: ask a doctor
    • FOR BEST RESULTS apply to clean, dry skin
    • tear open pouch and remove patch; if desired, cut patch to size
    • grasp both ends of the patch firmly with thumbs near center
    • stretch patch until the backing separates
    • remove protective film while applying patch directly to site of pain
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  • Inactive ingredients

    aloe barbadensis leaf juice, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, maltodextrin, partially hydrolized polyvinyl alcohol, partially neutralized polycrylates, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid, vitamin E

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  • Questions?

    Toll free 1-877-636-2677 MON - FRI 9AM to 5PM (EST)  

    www.wellpatch.com

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  • Package/Label Principal Display Panel

    WellPatch Backache Pain Relief Patch

    Topical Analgesic with 5% Menthol

    The Mentholatum Company

    Orchard Park, NY 14127

    Made in China

    WellPatch Backache Pain Relief Patch
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  • Package/Label Principal Display Panel

    WellPatch Backache Pain Relief Pouch

    WellPatch Pain Relief Patch
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  • INGREDIENTS AND APPEARANCE
    WELLPATCH BACKACHE PAIN RELIEF 
    menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8123
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CARBOXYMETHYLCELLULOSE SODIUM  
    DIHYDROXYALUMINUM AMINOACETATE  
    EDETATE DISODIUM  
    GLYCERIN  
    ISOPROPYL MYRISTATE  
    MALTODEXTRIN  
    POLYVINYL ALCOHOL  
    POLYACRYLIC ACID (250000 MW)  
    POLYSORBATE 80  
    WATER  
    SORBITAN SESQUIOLEATE  
    SORBITOL  
    TALC  
    TARTARIC ACID  
    ALPHA-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8123-1 1 in 1 CARTON
    1 4 in 1 POUCH
    2 NDC:10742-8123-2 3 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/18/2008
    Labeler - The Mentholatum Company (002105757)
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