Mr Dudleys Topical Cycle Relief with Nutmeg

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor arthritis pain, backache, muscle strains, sprains, and menstrual 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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse. This formulation is intended for external use only and should be applied strictly as directed.

Application to wounds or broken skin is contraindicated. In the event of redness or irritation at the application site, the use of the product should be discontinued immediately, and a healthcare professional should be consulted for further evaluation.

Care should be taken to avoid tight bandaging or the use of heating pads on the treated area, as these practices may exacerbate irritation or lead to adverse effects. Should the condition persist beyond five days, it is essential to discontinue use and seek medical advice.

Additionally, contact with the eyes and other mucous membranes must be avoided to prevent potential complications. For individuals who are pregnant or nursing, it is crucial to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients may experience various adverse reactions while using the product. It is important to monitor for signs of redness; if redness occurs, patients should discontinue use and consult a doctor. Should the condition persist for more than five days, discontinuation of use is advised, along with seeking medical consultation.

Additionally, patients are cautioned to avoid contact with the eyes and other mucous membranes to prevent potential complications. These precautions are essential to ensure the safe use of the product and to mitigate any adverse effects that may arise.

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 Cycle Relief with Nutmeg (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children and to use it only as directed for external use. It is important to avoid application on wounds or broken skin. In the event of redness, use should be discontinued, and a healthcare professional should be consulted. If the condition persists for more than 5 days, discontinuation of use and consultation with a doctor is recommended. Additionally, pregnant or nursing individuals should seek the advice of a healthcare professional prior to using this product.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those nursing a baby should seek the advice of a healthcare professional before using this product. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when making recommendations.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

Patients should apply the product generously, massaging it into the affected area until it is thoroughly absorbed into the skin. This application can be repeated as needed for pain relief, but should not exceed four times a day.

Clinicians are advised to counsel patients to seek the advice of a healthcare professional if they are pregnant or nursing before using this product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)