Overnight Relief Gel-Patch

Description

The drug is formulated as a transdermal patch, designed for the delivery of active ingredients through the skin. This dosage form allows for sustained release and systemic absorption, providing an alternative to oral or injectable routes of administration. The patch is characterized by its adhesive backing, which ensures secure application to the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children 12 years of age and older should begin by cleaning and drying the affected area. The protective film should be popped apart and partially peeled back to expose the gel-patch. The exposed gel-patch is then applied directly to the site of pain. Care should be taken to remove the remaining film while pressing the gel-patch firmly against the skin. The gel-patch should be left in place for a maximum duration of 8 hours. It is recommended that the gel-patch be used on affected areas no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a physician prior to use.

After application, hands should be washed thoroughly with cool water to ensure cleanliness.

Contraindications

The product is contraindicated in the following situations:

Application is not recommended on wounds or damaged skin, as well as on irritated skin or in cases where excessive irritation develops. Additionally, do not apply tightly bandaged or in conjunction with heating pads or devices, due to the risk of increased irritation or adverse effects.

Contact with eyes or mucous membranes should be avoided to prevent irritation.

If burning discomfort or excessive skin irritation occurs, or if the condition worsens, persists beyond 7 days, or recurs within a few days, discontinue use and consult a healthcare professional. Furthermore, if pain, swelling, or blistering of the skin develops, or if arthritic pain persists for more than 10 days with accompanying redness, seek medical advice.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is imperative that the product is not applied to wounds, damaged skin, or irritated areas. In cases where excessive irritation develops, application should be discontinued. Additionally, patients should be cautioned against tightly bandaging the area of application or using heating pads or devices concurrently.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use. It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist beyond 7 days or resolve only to recur within a few days. Furthermore, if arthritic pain continues for more than 10 days or if redness is observed, medical advice should be sought.

In cases of accidental ingestion, emergency medical help must be obtained immediately, or a Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed and to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and should not be bandaged tightly or used in conjunction with heating pads or devices.

In clinical trials and postmarketing experiences, patients have reported various adverse reactions. Serious reactions may include pain, swelling, or blistering of the skin. Patients are advised to stop use and consult a doctor if they experience any of these symptoms, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days. Additionally, if arthritic pain persists for more than 10 days or if redness is present, medical advice should be sought.

Common adverse reactions may include burning discomfort or excessive skin irritation. Patients should discontinue use and consult a healthcare professional if these symptoms develop or if the condition worsens.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this product. It is crucial to keep the product out of reach of children, and in the event of accidental ingestion, medical help should be sought or a Poison Control Center contacted immediately.

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 Overnight Relief Gel-Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents aged 12 years and older, the application involves cleaning and drying the affected area, then partially peeling back the protective film to apply the exposed gel-patch to the site of pain. The remaining film should be carefully removed while pressing the gel-patch to the skin, and it may be left in place for up to 8 hours. The gel-patch should not be used on affected areas more than 3 to 4 times daily.

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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional before use. This recommendation applies to both teratogenic and non-teratogenic effects. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the provided data.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to instruct patients not to apply the product to wounds or damaged skin, and to avoid use on irritated skin or if excessive irritation develops.

Patients should be informed that while using this product, it is essential to follow the directions provided. They should be cautioned against contact with the eyes and mucous membranes, and reminded not to apply the product to wounds or damaged skin. Additionally, patients should not use the product on irritated skin or if they experience excessive irritation. They should also avoid tightly bandaging the area or using heating pads or devices in conjunction with the product.

Healthcare providers should encourage patients to discontinue use and consult a doctor if they experience burning discomfort, excessive skin irritation, worsening of their condition, or if symptoms persist for more than 7 days. Patients should also be advised to seek medical advice if symptoms clear up and then recur within a few days, if they experience pain, swelling, or blistering of the skin, or if arthritic pain persists for more than 10 days, especially if redness is present.

For patients who are pregnant or breastfeeding, it is crucial to recommend that they consult a health professional before using the product.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20-25℃ (68-77℉) in a cool, dry place, away from direct sunlight. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, the affected area should be cleaned and dried before applying the gel-patch. The protective film should be partially peeled back to expose the gel-patch, which is then pressed onto the site of pain. The remaining film is carefully removed while ensuring the gel-patch adheres to the skin, and it can be left in place for up to 8 hours. The gel-patch should not be used on affected areas more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Overnight Relief Gel-Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)