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

  • NDC Code(s): 10742-2002-4
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 18, 2019

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  • Active ingredients

    Menthol 8%

    Methyl salicylate 30%

  • Purpose

    Menthol - External analgesic

    Methyl salicylate - External analgesic

  • Uses

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

    arthritis
    strains
    simple backache
    sprains
  • 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, other heat sources, or right after a shower/bath
    do not use in combination with other external analgesic products

    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

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

    Keep out of reach of children.

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

  • 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
  • Inactive ingredients

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

  • Questions?

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

    www.mentholatum.com

  • Package/Label Principal Display Panel

    Mentholatum Deep Heating Pain Relieving Rub
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM DEEP HEATING RUB  EXTRA STRENGTH
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-2002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM80 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-2002-42 in 1 CARTON12/15/1992
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/15/1992
    Labeler - The Mentholatum Company (002105757)