Active Ingredient
Menthol 2.5%
Mr Dudleys Topical Cycle Relief With Nutmeg
FDA Label NDC 58484-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dudley Wellness Company Inc for the product Mr Dudleys Topical Cycle Relief With Nutmeg (NDC 58484-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, indications and usage, warnings, dosage and administration., inactive ingredient., principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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