MR DUDLEYS TOPICAL PAIN RELIEF - 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 Facts

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 the reach of children

Warnings:

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

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)

Revised: 5/2013
Document Id: e912b891-a457-4224-8a5b-7b7cb2b9a268
Set id: ec239064-987a-4341-acb6-b4de3a6e76be
Version: 1
Effective Time: 20130510
 
DUDLEY WELLNESS COMPANY INC