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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)

 
DUDLEY WELLNESS COMPANY INC

Medically reviewed on May 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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