Label: MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG- 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 October 24, 2013

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  • Active Ingredient

    Menthol 2.5%

  • Purpose

    Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

  • Keep out of reach of children

  • Indications and Usage

    Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

    Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

  • Warnings

    Keep out of reach of children.

    For esternal use only, use only as directed.

    Donot apply to wound or broken skin.

    If redness present discontinue 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.

  • Dosage and administration.

    Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

  • Inactive ingredient.

    Water

    SD Alcohol

    Glycerine

    PEG-440 Hydrogenated Castor Oil

    Methyl Salicylate

    Caprylic Capric Triglyceride

    Sodium Acrylate Copolymer

    Eugenol

    Methyl Eugenol

    Nutmeg Oil

    Methyllisoeugenol

    Methoxy Eugenol

    Blue # 1

  • Principal Display panel

    image description

  • INGREDIENTS AND APPEARANCE
    MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58484-200
    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
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    EUGENOL (UNII: 3T8H1794QW)  
    METHYL EUGENOL (UNII: 29T9VA6R7M)  
    NUTMEG OIL (UNII: Z1CLM48948)  
    METHYL ISOEUGENOL (UNII: 46RN7Q97DE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58484-200-45128 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/24/2013
    Labeler - Dudley Wellness Company Inc (078816740)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dudley Manufacturing LLC830613076manufacture(58484-200)
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