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

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Drug Label Information

Updated February 7, 2023

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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, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

  • Questions?

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

    www.mentholatum.com

  • Package/Label Principal Display Panel

    Deep Heating PDP
  • Principal Display Panel

    Drug Facts
  • 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)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-2002)
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