Label: MENTHOLATUM PAIN RELIEVING- menthol, methyl salicylate lotion

  • NDC Code(s): 10742-8169-1, 10742-8169-2
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredients

    Menthol 6%

    Methyl salicylate 20%

  • Purpose

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

  • Uses

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

    • arthritis
    • simple backache
    • strains
    • 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 to damaged skin
    • do not bandage tightly
    • do not use with a 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 12 years and over: apply to affected area not more than 3 to 4 times daily
    • children under 12 years: ask a doctor
  • Inactive ingredients

    carbomer, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

  • Package/Label Principal Display Panel

    Mentholatum Pain Relieving Lotion
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM PAIN RELIEVING 
    menthol, methyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8169
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8169-11 in 1 CARTON11/01/2018
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:10742-8169-21 in 1 CARTON11/01/2018
    275 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8169)
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