Mr Dudleys Topical Cycle Relief with Nutmeg

Manufacturer: Dudley Wellness Company Inc | Dudley Manufacturing LLC
Effective date: 2013-10-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:37:20

Label at a glance#

ProductMr Dudleys Topical Cycle Relief with Nutmeg

Active ingredientMENTHOL

Label structure7 sections

Indications and uses

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.

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

Purpose

OTC - PURPOSE SECTION

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Indications and Usage

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1291226	menthol 2.5 % Topical Cream	PSN	1
1291226	menthol 25 MG/ML Topical Cream	SCD	1
1291226	menthol 2.5 % Topical Cream	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58484-200-45	2019-11-27	C162847	48780-1	9855e2a2-3a4d-60a7-e053-dbdaa90a05bd	Drug Fact

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58484-200-45	Mr Dudleys Topical Cycle Relief with Nutmeg	128 g in 1 BOTTLE	CREAM	128		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58484-200	MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG (MENTHOL) CREAM [DUDLEY WELLNESS COMPANY INC]	1	Legacy NDC, 1 package rows	20131030_5b4e7f72-8845-492a-afab-30f2d4556384.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
ACRYLAMIDE	INACTIVE INGREDIENT	20R035KLCI	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
METHYL EUGENOL	INACTIVE INGREDIENT	29T9VA6R7M	1
METHYL ISOEUGENOL	INACTIVE INGREDIENT	46RN7Q97DE	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	1
NUTMEG OIL	INACTIVE INGREDIENT	Z1CLM48948	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Mr Dudleys Topical Cycle Relief with Nutmeg
Menthol
Methyl Salicylate
Water
ALCOHOL
GLYCERIN
POLYOXYL 40 HYDROGENATED CASTOR OIL
MEDIUM-CHAIN TRIGLYCERIDES
ACRYLAMIDE
EUGENOL
METHYL EUGENOL
NUTMEG OIL
METHYL ISOEUGENOL
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58484-200	58484-200-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
Methyl Salicylate	LAV5U5022Y	IACT
Water	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
ACRYLAMIDE	20R035KLCI	IACT
EUGENOL	3T8H1794QW	IACT
METHYL EUGENOL	29T9VA6R7M	IACT
NUTMEG OIL	Z1CLM48948	IACT
METHYL ISOEUGENOL	46RN7Q97DE	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	TABLET / ORAL		120 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	POWDER / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER / SUBLINGUAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CREAM / TOPICAL		3300 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYOXYL 40 HYDROGENATED CASTOR OIL	POLYOXYL 40 HYDROGENATED CASTOR OIL	7YC686GQ8F	SOLUTION / DENTAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2b2b2e5d-ad74-4d36-ac5a-615a027bc5cc			5b4e7f72-8845-492a-afab-30f2d4556384	2013-10-24	Warnings	Exact identifier spl id: 2b2b2e5d-ad74-4d36-ac5a-615a027bc5cc spl set id: 5b4e7f72-8845-492a-afab-30f2d4556384

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.