Dr Sabharwals

Description

The Menthol 5% Patch is a topical dosage form designed for the delivery of menthol. It contains 5% menthol as the active ingredient, which is known for its counterirritant properties. The patch is formulated to provide localized relief through the skin. The appearance of the patch is consistent with standard transdermal delivery systems, allowing for effective application and adherence 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

The Topical Pain Relief Patch is intended for external use only. Healthcare professionals should instruct patients to apply the patch to clean, dry skin at the site of pain.

The recommended dosing is one patch applied every 12 hours, not to exceed two patches in a 24-hour period. The patch should be left in place for a maximum of 12 hours before removal.

Prior to application, the area should be inspected for any signs of irritation or broken skin. If irritation occurs, the patch should be removed immediately, and the area should be washed with soap and water.

Patients should be advised to wash their hands thoroughly after handling the patch, and to avoid applying the patch to sensitive areas such as the eyes or mucous membranes.

Contraindications

Use of this product is contraindicated in the following situations:

The application of more than one patch on the body at a time is prohibited. The product should not be applied to cut, irritated, or swollen skin, as well as puncture wounds or any damaged skin, due to the risk of exacerbating these conditions. Prolonged use beyond one week without consulting a healthcare professional is not advised.

The product must not be used in conjunction with heating pads, as this may increase the risk of adverse effects. Additionally, it is contraindicated for use in children under 12 years of age with arthritis-like conditions.

Contact with eyes and mucous membranes should be avoided. The product should not be bandaged tightly or subjected to local heat, and it should not be used simultaneously with other topical analgesics. Used patches must be disposed of properly to prevent access by children and pets, as they may still contain active drug that can lead to serious adverse effects if ingested. Discontinue use at least one hour prior to bathing or showering, and do not apply the patch immediately after bathing or showering.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Caution should be exercised to avoid application on wounds or any damaged, broken, or irritated skin. There have been rare reports of serious burns associated with products of this nature. Care must be taken to prevent contact with the eyes and mucous membranes. Additionally, it is advised not to bandage the area of application tightly or apply local heat, such as heating pads, to the site of use. Concurrent use with other topical analgesics is contraindicated.

Used patches must be disposed of properly to ensure they remain out of reach of children and pets, as they still contain the drug product, which can lead to serious adverse effects if ingested. A transient burning sensation may occur upon application; however, this typically resolves within several days. Should a severe burning sensation arise, the product should be discontinued immediately. It is also recommended to refrain from using the product at least one hour prior to bathing or showering, and not to apply it immediately after such activities.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of the condition, presence of redness over the affected area, excessive skin irritation, persistence of symptoms beyond seven days, recurrence of symptoms after initial improvement, or any signs of skin injury, including pain, swelling, or blistering at the application site.

Side Effects

Patients using the product should be aware that it is intended for external use only. In clinical observations, some participants have reported a worsening of their condition following application. Common adverse reactions include the presence of redness over the affected area and excess skin irritation.

Additionally, patients should monitor their symptoms closely; if symptoms persist for more than 7 days, or if they clear up and then recur within a few days, it is advised to seek medical attention. Signs of skin injury, such as pain, swelling, or blistering at the site of application, have also been noted and warrant immediate consultation with a healthcare professional.

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 efficacy of treatment. Monitoring for any signs of increased irritation or adverse reactions is recommended if there is a need to transition between topical analgesics.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Sabharwals (menthol 5% patch). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children aged 12 years or younger, it is advised to consult a healthcare professional before use.

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 potential adverse effects or changes in efficacy, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed data does not preclude the possibility of adverse effects. Symptoms of overdose 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the situation at hand.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Upon application, a transient burning sensation may occur; however, this sensation typically resolves within several days. In the event of a severe burning sensation, it is recommended to discontinue use immediately.

No specific information regarding carcinogenicity, mutagenicity, or impairment of fertility has been provided. Additionally, there is no available data pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. It has been noted that used patches may still contain the drug product, which can lead to serious adverse effects if chewed or ingested by children or pets. Users may experience a transient burning sensation upon application, which typically resolves within several days. However, if a severe burning sensation occurs, it is advised to discontinue use immediately. Additionally, discontinuation is recommended if the condition worsens, if redness is observed over the affected area, if excess skin irritation occurs, if symptoms persist for more than 7 days or recur after resolution, or if signs of skin injury such as pain, swelling, or blistering are present at the application site.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to use the product only as directed and to read and follow all directions and warnings on the label carefully. It is important to highlight that rare cases of serious burns have been reported with similar products, and therefore, patients should not apply the product to wounds or damaged, broken, or irritated skin.

Healthcare providers should caution patients against allowing the product to come into contact with eyes and mucous membranes. Additionally, patients should be advised not to bandage the area tightly or apply local heat, such as heating pads, to the site of application. It is also essential to inform patients not to use the product concurrently with other topical analgesics.

Patients should be instructed on the proper disposal of used patches, ensuring that they are kept away from children and pets, as used patches still contain the drug product that can lead to serious adverse effects if ingested.

A transient burning sensation may occur upon application, but this typically resolves within several days. Patients should be advised to discontinue use immediately if a severe burning sensation occurs. Furthermore, it is important to instruct patients to discontinue use at least one hour before bathing or showering and to avoid using the product immediately after a bath or shower.

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 at room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than three times daily for adults and children over 12 years. It is important to note that the patch should not be worn for more than eight hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Additionally, it is crucial to keep the product out of reach of children and pets. 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 Dr Sabharwals, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)