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
  • 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 February 7, 2023

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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 not finalpart34811/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8169)
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