Healthwise Overnight Menthol Patch

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side of the patch should be applied directly to the affected area. It is important to note that no more than one patch should be used in an 8-hour period. The patch may be reapplied as necessary, with a maximum of three patches permitted per day. Each patch is for single use only and should be discarded after application.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Infants: The product should not be applied to infants due to potential safety concerns.

• Worsening condition: Discontinue use if the condition worsens.

• Redness: Do not use if redness is present at the application site.

• Irritation: If irritation develops, discontinue use immediately.

• Persistent symptoms: If symptoms persist for more than 7 days or if they resolve and recur within a few days, do not continue use.

• Signs of injury: Discontinue use if there are signs of injury, such as pain, swelling, or blistering at the application site.

• Tight bandaging or heating pads: Avoid tight bandaging or the use of heating pads in conjunction with this product.

• Contact with eyes and mucous membranes: The product should not come into contact with eyes or mucous membranes.

• Wounds or damaged skin: Do not apply to wounds or damaged skin.

• Concurrent use with other topical analgesics: The product should not be used simultaneously with other topical analgesics.

Warnings and Precautions

For external use only. This product is not intended for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Serious burns, although rare, have been reported with the use of similar products. To minimize the risk of adverse effects, it is crucial to avoid tight bandaging and the application of heating pads in conjunction with this product. Care should be taken to prevent contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Concurrent use with other topical analgesics is contraindicated.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Additionally, patients should be instructed to report any signs of injury, such as pain, swelling, or blistering at the application site.

In cases of ingestion, immediate medical help is essential, and the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of worsening conditions, the presence of redness, or the development of irritation, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms persist for more than 7 days, or if they resolve and then recur within a few days, medical advice should be sought.

Patients should also be vigilant for signs of injury at the application site, which may include pain, swelling, or blistering. In such cases, it is imperative to stop using the product and seek medical attention.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern for inadvertent overlap in therapy.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. The product is not indicated for infants; if ingested, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is advised.

For children aged 12 years and older, the application involves cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side applied to the affected area. No more than one patch should be used within an 8-hour period, with a maximum of three patches permitted per day. Each patch is for single use only and should be discarded after application.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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 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 for suspected cases of drug overdosage.

Recommended Actions In the event of an overdosage, it is essential to assess the patient's clinical status promptly. Healthcare providers should initiate supportive care measures, which may include monitoring vital signs and providing symptomatic treatment as necessary.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive intake of the medication.

Management Procedures Management of overdosage should be tailored to the individual patient and may involve the use of activated charcoal if the ingestion occurred within a suitable timeframe. Additionally, healthcare providers should consider contacting a poison control center for further guidance on the management of the specific substance involved.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and remain observant for any adverse effects in patients.

Nonclinical Toxicology

There are no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects have been reported. The available data does not provide any specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports underscores the importance of ongoing monitoring and evaluation of product safety in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients not to use this product on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to monitor their condition closely. They should report to their healthcare provider if their condition worsens, if redness is present, or if irritation develops. Additionally, patients should be counseled to seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important to instruct patients to be vigilant for signs of injury at the application site, such as pain, swelling, or blistering, and to discontinue use and consult a healthcare provider if these occur. Patients should use the product only as directed and be made aware that rare cases of serious burns have been reported with similar products.

Healthcare providers should emphasize that patients should not bandage the area tightly or use a heating pad in conjunction with the product. Patients should also be advised to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. Furthermore, patients should be informed not to use this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a configuration that allows for single use. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). After use, the patch must be discarded to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)