Label: MENTHOLATUM PAIN RELIEF EXTRA STRENGTH- menthol gel

  • NDC Code(s): 10742-8134-1
  • 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

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

  • Active ingredient

    Menthol 3%

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  • Purpose

    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 bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • excessive irritation, burning or discomfort of the skin develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
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  • If pregnant or breast-feeding,

    ask a healthcare professional before use.

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  • 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 not more than 3 to 4 times daily
    • children under 12 years: ask a doctor
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  • Inactive ingredients

    carbomer, iron oxides, isopropyl alcohol, methylparaben, mica, propylparaben, purified water, titanium dioxide, trolamine

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  • Questions?

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

    Distributed by:

    The Mentholatum Company

    Orchard Park, NY 14127

    Made in Canada

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  • Package/Label Principal Display Panel

    Mentholatum Pain Relief Extra Strength Gel Menthol 3%

    Mentholatum Pain Relief Extra Strength Gel

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  • Package/Label Principal Display Panel

    Active ingredient Menthol 3% Topical analgesic

    Distributed by:

    The Mentholatum Company

    Orchard Park, NY 14127

    Made in Canada

    Close
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM PAIN RELIEF EXTRA STRENGTH 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-8134
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    METHYLPARABEN  
    MICA  
    PROPYLPARABEN  
    WATER  
    TITANIUM DIOXIDE  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-8134-1 236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 08/08/2011
    Labeler - The Mentholatum Company (002105757)
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