MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG- menthol cream 
Dudley Wellness Company Inc

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.

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Drug Fact

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

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)

Revised: 10/2013
Document Id: 2b2b2e5d-ad74-4d36-ac5a-615a027bc5cc
Set id: 5b4e7f72-8845-492a-afab-30f2d4556384
Version: 1
Effective Time: 20131024
 
Dudley Wellness Company Inc