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 a convenient and effective method 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 must then be applied directly to the site of pain. While pressing the gel-patch to the skin, the remaining film should be carefully removed. The gel-patch should be left in place for a maximum 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, consultation with a physician is advised 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 prohibited on wounds or damaged skin due to the potential for exacerbating injury and delaying healing. It should not be used on irritated skin or if excessive irritation develops, as this may worsen the condition. Additionally, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to increased irritation or adverse effects.

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

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. Should excessive irritation develop, discontinuation of use is recommended. Additionally, patients should be cautioned against tightly bandaging the area of application or using heating pads or devices in conjunction with the product.

Pregnant or breastfeeding individuals should 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 advised.

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; persistence of symptoms beyond 7 days; or recurrence of symptoms after a brief improvement. 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 without delay, and contacting a Poison Control Center is strongly recommended.

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 or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, especially if excessive irritation develops. Additionally, patients should refrain from tightly bandaging the area or using it in conjunction with heating pads or devices.

In clinical observations, patients are advised to stop use and consult a doctor if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 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 present, medical advice should be sought.

Pregnant or breastfeeding patients are encouraged to consult a healthcare professional prior to using this product. It is also crucial to keep the 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 particularly vigilant for burning discomfort or excessive skin irritation, as these symptoms may indicate the need to discontinue use and consult a healthcare provider.

Drug Interactions

There are no specific drug interactions identified for the product, as indicated in the labeling. Additionally, no laboratory test interactions have been documented. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 can offer guidance tailored to individual circumstances, ensuring informed decision-making for both maternal and fetal health.

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 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 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 of the patient's condition are essential to ensure appropriate therapeutic interventions are implemented.

In all cases of suspected overdosage, the involvement of medical professionals is vital to ensure the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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 postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed and to avoid contact with the eyes and mucous membranes. Patients should be informed not to apply the medication to wounds, damaged skin, or irritated skin, and to discontinue use if excessive irritation develops.

It is important to instruct patients not to bandage the area tightly or use heating pads or devices in conjunction with the medication. Patients should be counseled to stop use and consult a doctor if they experience burning discomfort, excessive skin irritation, or if their condition worsens. They should also seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Additionally, patients should be made aware that if they experience pain, swelling, or blistering of the skin, they should stop use and contact a healthcare professional. For those with arthritic pain, it is essential to inform them to seek medical advice if the pain persists for more than 10 days or if redness is present.

Finally, healthcare providers should remind patients who are pregnant or breastfeeding to consult a health professional before using the medication. In the event of accidental ingestion, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25℃ (68-77℉). Additionally, the product should be kept in a cool, dry place, away from direct sunlight to ensure its integrity and efficacy. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily on the affected areas. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the medication out of reach of children; in the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center 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)