Label: MENTHOL DAVIS ANALGESIC- menthol ointment

  • NDC Code(s): 82480-000-01
  • Packager: Genia Care Phamaceutical S.A.
  • 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 June 13, 2022

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  • Drug Facts

  • Active ingredient

    Menthol 5%

    Purpose

    Topical Analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints

  • Warnings

    For external use only.

    When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    condition worsens, or if 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 of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
  • Other information

    Store in a cool, dry, ventilated place, away from all sources of heat, ignition, and combustion.

  • Inactive ingredients

    Paraffin wax, petrolatum.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MENTHOL DAVIS ANALGESIC 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82480-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82480-000-011 in 1 BLISTER PACK09/04/2023
    128 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/04/2023
    Labeler - Genia Care Phamaceutical S.A. (817305769)
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