Label: MR DUDLEYS TOPICAL PAIN RELIEF- menthol cream

  • 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 May 10, 2013

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  • Active Ingredient:


    Menthol 2.5%


  • Purpose:

    Topical Analgesic

  • Uses:


    For the temporary relief of minor arthritis pain, backache, muscle strains and cramps.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

  • Warnings:

    • For external use only.
    • Use only as directed.
    • Do not apply to wounds or damaged skin.
    • If redness is present, discontinue use and consult a doctor.
    • Do not bandage tightly or use a heating pad.
    • If the condition persists for more than 5 days, discontinue use and consult a doctor.
    • Avoid contact with eyes and other mucous membranes.
    • If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
  • Directions:

    Apply generously and massage into the affected area until thoroughly absorbed into the skin. Repeat as needed for pain, but not more than 4 times per day.

  • Inactive Ingredients:


    Water, SD Alcohol, Glycerine, PEG-40 Hydrogenated Castor Oil, Methyl Salicylate, Caprylic Capric Triglyceride, Sodium Acrylate Copolymer, Eugenol, Methyl Eugenol, Nutmeg Oil, Methyllisoeugenol, Methoxy Eugenol, Blue #1


  • Product Label

    Drug Label

  • INGREDIENTS AND APPEARANCE
    MR DUDLEYS TOPICAL PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58484-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    EUGENOL (UNII: 3T8H1794QW)  
    METHYL EUGENOL (UNII: 29T9VA6R7M)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    METHYL ISOEUGENOL (UNII: 46RN7Q97DE)  
    4-ALLYL-2,6-DIMETHOXYPHENOL (UNII: 8VF00YWP89)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58484-100-01.2 g in 1 BOTTLE
    2NDC:58484-100-051.4 g in 1 BOTTLE
    3NDC:58484-100-2057 g in 1 BOTTLE
    4NDC:58484-100-45128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/13/2013
    Labeler - DUDLEY WELLNESS COMPANY INC (078816740)
    Establishment
    NameAddressID/FEIBusiness Operations
    DUDLEY MANUFACTURING LLC.830613076manufacture(58484-100)
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