Mr Dudleys Topical Pain Relief

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor arthritis pain, backache, muscle strains, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to apply the medication generously to the affected area and massage it into the skin until it is thoroughly absorbed. This application may be repeated as needed for pain relief, with a maximum frequency of four times per day.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only, this product should be applied strictly as directed. It is imperative that the product is not applied to wounds or damaged skin to prevent adverse reactions. In the event of redness or irritation, the use of the product should be discontinued immediately, and a healthcare professional should be consulted.

Healthcare professionals should advise patients against tightly bandaging the area of application or using a heating pad, as these practices may exacerbate potential side effects. Should the condition persist beyond five days, it is essential to discontinue use and seek medical advice.

Additionally, care must be taken to avoid contact with the eyes and other mucous membranes, as this may lead to irritation or other complications. Pregnant or nursing individuals are strongly encouraged to consult with a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product may experience adverse reactions, particularly if the product is not used as directed. It is important to note that this product is for external use only and should not be applied to wounds or damaged skin. In clinical observations, participants have reported instances of redness at the application site. If redness occurs, patients are advised to discontinue use and consult a healthcare professional.

Additionally, patients should avoid bandaging the area tightly or using a heating pad, as these practices may exacerbate adverse reactions. If the condition persists for more than five days, it is recommended that patients discontinue use and seek medical advice.

Care should also be taken to avoid contact with the eyes and other mucous membranes, as this may lead to further complications. Pregnant or nursing individuals are advised to consult a healthcare professional prior to using this product to ensure safety for both themselves and their child.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mr Dudleys Topical Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of the reach of children. This precaution is essential to ensure safety and prevent accidental ingestion or misuse.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and nursing mothers are advised to seek the counsel of a healthcare professional prior to using this product. The potential risks and benefits should be carefully considered in consultation with a qualified provider to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers are advised to seek the advice of a healthcare professional before using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals.

Storage and Handling

The product is supplied in a configuration suitable for external use only. It is essential to store the product at room temperature, ensuring it is kept out of the reach of children. Care should be taken to avoid application on wounds or damaged skin. Once opened, the product should be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommendation to apply generously and massage into the affected area until fully absorbed. Patients may repeat this application as needed for pain, not exceeding four times per day.

Clinicians should counsel patients to keep the product out of the reach of children and to use it only as directed for external use. It should not be applied to wounds or damaged skin, and if redness occurs, patients should discontinue use and consult a doctor. Additionally, patients are advised against tightly bandaging the area or using a heating pad. If symptoms persist beyond five days, they should seek medical advice. Care should be taken to avoid contact with eyes and mucous membranes, and pregnant or nursing individuals should consult a healthcare professional prior to use.

Drug Information (PDF)

This file contains official product information for Mr Dudleys Topical Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)