Label: EUCALYPTAMINT- menthol ointment

  • 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 July 20, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 16%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • sore muscles
    • simple backache
    • strains
    • sprains
  • Warnings

    For external use only

    Do not use

    • other than as directed
    • with a heating pad or heating device

    When using this product

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

    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: gently massage a conservative amount into affected area not more than 3 to 4 times daily.
    • children under 2 years of age: consult a doctor
    • if thickening of product occurs, warm tube in palm of hand or run under warm water.
  • Other information

    • store at room temperature
    • see box or crimp of tube for lot number and exp. date
  • Inactive ingredients

    Eucalyptus Oil, Lanolin, Mineral Oil, White Petrolatum

  • QUESTIONS

    Call 1-800-344-7239 or write to Consumer Affairs at address below.

  • SPL UNCLASSIFIED SECTION

    Dist. by: INSIGHT Pharmaceuticals Corp., Langhorne, PA 19047-1749

    63005H

  • PRINCIPAL DISPLAY PANEL - Tube Label

    MAXIMUM STRENGTH

    Eucalyptamint
    OINTMENT 16% MENTHOL®

    ARTHRITIS PAIN RELIEF FORMULA

    NET WT. 2 FL. OZ. (60mL)

    PRINCIPAL DISPLAY PANEL - Tube Label
  • PRINCIPAL DISPLAY PANEL - Carton Label

    Eucalyptamint
    OINTMENT 16% MENTHOL®

    ARTHRITIS PAIN RELIEF FORMULA

    EASY OPENING TUBE
    NET WT. 2 FL. OZ. (60mL)

    PRINCIPAL DISPLAY PANEL - Carton Label
  • INGREDIENTS AND APPEARANCE
    EUCALYPTAMINT 
    menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol9.6 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-340-021 in 1 BOX
    160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/09/2009
    Labeler - Insight Pharmaceuticals (176792315)
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