Label: MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH- menthol and methyl salicylate cream

  • NDC Code(s): 10742-2002-4, 10742-2002-5
  • 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 12/13

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  • Active ingredients

    Menthol 8%

    Methyl salicylate 30%

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  • Purpose

    Menthol - External analgesic

    Methyl salicylate - External analgesic

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  • Uses

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

    arthritis
    strains
    simple backache
    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 damaged skin
    do not bandage tightly
    do not use with heating pad or apply external heat

    Stop use and ask a doctor if

    condition worsens
    excessive irritation 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 2 years and over: apply to affected area not more than 3 to 4 times daily
    children under 2 years: ask a doctor
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  • Inactive ingredients

    glyceryl stearate, isoceteh-20, poloxamer 407, purified water, quaternium-15, sodium lauryl sulfate, sorbitan stearate

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  • Questions or comments?

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

    www.mentholatum.com

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM DEEP HEATING RUB  EXTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10742-2002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 80 mg  in 1 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 300 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERYL MONOSTEARATE  
    POLOXAMER 407  
    WATER  
    QUATERNIUM-15  
    SODIUM LAURYL SULFATE  
    SORBITAN MONOSTEARATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10742-2002-4 2 in 1 CARTON
    1 57 g in 1 TUBE
    2 NDC:10742-2002-5 57 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/15/1992
    Labeler - The Mentholatum Company (002105757)
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