MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG- menthol cream

Mr Dudleys Topical Cycle Relief with Nutmeg by

Drug Labeling and Warnings

Mr Dudleys Topical Cycle Relief with Nutmeg 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

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

INGREDIENTS AND APPEARANCE

MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58484-200
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58484-200-45	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	10/24/2013

Labeler - Dudley Wellness Company Inc (078816740)

Establishment
Name	Address	ID/FEI	Business Operations
Dudley Manufacturing LLC		830613076	manufacture(58484-200)