MR DUDLEYS TOPICAL PAIN RELIEF- menthol cream

Mr Dudleys Topical Pain Relief by

Drug Labeling and Warnings

Mr Dudleys Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by DUDLEY WELLNESS COMPANY INC, DUDLEY MANUFACTURING LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

MR DUDLEYS TOPICAL PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58484-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58484-100-01	.2 g in 1 BOTTLE
2	NDC: 58484-100-05	1.4 g in 1 BOTTLE
3	NDC: 58484-100-20	57 g in 1 BOTTLE
4	NDC: 58484-100-45	128 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/13/2013

Labeler - DUDLEY WELLNESS COMPANY INC (078816740)

Establishment
Name	Address	ID/FEI	Business Operations
DUDLEY MANUFACTURING LLC.		830613076	manufacture(58484-100)