Active Ingredient:
Menthol 2.5%
Mr Dudleys Topical Pain Relief
FDA Label NDC 58484-100
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 Pain Relief (NDC 58484-100). 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:, uses:, otc - keep out of reach of children, warnings:, directions:, inactive ingredients:, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
Topical Analgesic
Uses:
For the temporary relief of minor arthritis pain, backache, muscle strains and cramps.
Otc - 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
Drug Label (Dudley)
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