Label: MENTHOLATUM ORIGINAL- camphor, menthol ointment

  • NDC Code(s): 10742-0002-1, 10742-0002-2, 10742-0002-3, 10742-0002-4
  • 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 February 7, 2023

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  • Active ingredients

    Camphor 9%

    Menthol 1.3%

  • Purpose

    Camphor - Topical Analgesic

    Menthol - Topical Analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints

  • Warnings

    For external use only

    When using this product

    • do not get into eyes
    • do not apply to wounds or to damaged skin
    • do not bandage tightly
    • do not heat, microwave, or add to hot water as this may cause splattering and result in burns

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or 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.

  • 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

    fragrance, petrolatum, titanium dioxide

  • Questions?

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

  • Package/Label Principal Display Panel

    Mentholatum Original Ointment
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM   ORIGINAL
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)90 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM13 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-0002-11 in 1 CARTON12/01/2014
    128 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10742-0002-21 in 1 CARTON12/01/2014
    285 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:10742-0002-31 in 1 CARTON10/19/2020
    334 g in 1 JAR; Type 0: Not a Combination Product
    4NDC:10742-0002-41 in 1 CARTON10/19/2020
    4102.1 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2014
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-0002)
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