Cycle

Description

THE GOOD PATCH is a water-resistant topical patch designed for fast-acting pain relief. Each patch measures 2.3 inches by 3.7 inches and features a 4-way stretch fabric for enhanced comfort and flexibility. The formulation includes plant-derived menthol and black cohosh, providing a natural approach to pain management. Each package contains four patches, suitable for use during various cycles.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with cramps and simple backache.

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

Dosage and Administration

For adults and children over 12 years of age, the patch should be applied to the affected area, such as the abdomen or lower back, after removing the backing. The patch may be worn for a maximum duration of 8 hours. It is recommended that the patch be used no more than 3 to 4 times daily.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with other topical products, as this may lead to adverse effects. Application on open wounds, damaged, or irritated skin is contraindicated due to the potential for increased irritation or infection. Additionally, tight bandaging or the application of local heat, such as heating pads, to the treated area is not advised, as this may exacerbate local reactions or alter the product's efficacy.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid concurrent use with other topical products to prevent adverse reactions. Application on open wounds, damaged, or irritated skin is contraindicated. Additionally, users should refrain from tightly bandaging the treated area or applying local heat, such as heating pads, as these practices may exacerbate the risk of burns, which have been reported in rare instances with products containing menthol.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness or irritation develops, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Immediate medical attention should be sought if burning, swelling, or blistering occurs at the application site.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

General precautions should be observed, particularly for individuals who are pregnant or breastfeeding; consultation with a healthcare professional is recommended prior to use.

No specific laboratory tests are required for the safe use of this product.

Side Effects

Patients using this product should be aware that it is intended for external use only. In rare instances, burns have been reported with products of this type that contain menthol.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness or irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if patients experience burning, swelling, or blistering at the application site, they should seek medical advice promptly.

Drug Interactions

The use of this product is contraindicated in conjunction with other topical products, as this may lead to adverse effects or diminished efficacy.

Regarding drug and laboratory test interactions, there are no specific interactions reported. Therefore, no additional precautions or monitoring are necessary in this context.

Packaging & NDC

Below are the non-prescription pack sizes of Cycle (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

In rare cases, burns have been reported in association with products of this type that contain menthol. These events were identified through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness or irritation develops, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should seek medical advice if they experience burning, swelling, or blistering at the application site.

When using this product, it is essential for patients to use it only as directed. They should be cautioned against using it in conjunction with other topical products and advised not to apply it to open wounds, damaged, or irritated skin. Patients should also be informed not to bandage the area tightly or apply local heat, such as heating pads, to the treated area. It is important to note that in rare instances, burns have been reported with products of this type that contain menthol.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within the recommended temperature range and is protected from moisture.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)