MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG- menthol cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

Dudley Wellness Company Inc

INN (International Name):

MENTHOL

Composition:

MENTHOL 2.5 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG- MENTHOL CREAM
DUDLEY WELLNESS COMPANY INC
_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 FACT
ACTIVE INGREDIENT
Menthol 2.5%
PURPOS E
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
MR DUDLEYS TOPICAL CYCLE RELIEF WITH NUTMEG
menthol cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:58 48 4-20 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
2.5 g in 10 0 g
Dudley Wellness Company Inc
INACTIVE I