Medication Guide App

Mr Dudleys Topical Pain Relief

Dosage form: cream
Ingredients: MENTHOL 2.5g in 100g
Labeler: DUDLEY WELLNESS COMPANY INC
NDC Code: 58484-100

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 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:
  • 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

MR DUDLEYS TOPICAL PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58484-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
METHYL SALICYLATE 
MEDIUM-CHAIN TRIGLYCERIDES 
ACRYLAMIDE 
EUGENOL 
METHYL EUGENOL 
NUTMEG OIL 
METHYL ISOEUGENOL 
4-ALLYL-2,6-DIMETHOXYPHENOL 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
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/FEIOperations
DUDLEY MANUFACTURING LLC.830613076manufacture(58484-100)

Revised: 05/2013
 
DUDLEY WELLNESS COMPANY INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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