Rapid Relief Menthol Pain Patch

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white powder. Its chemical name is insert chemical name here. The formulation includes several inactive ingredients, which are list of inactive ingredients here.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, the following dosage and administration guidelines apply:

The patch should be applied to the affected area after carefully removing the backing. The sticky side of the patch must be placed directly on the skin. Each patch may be worn for a maximum of 8 hours. It is permissible to repeat the application as necessary, but no more than three patches should be used in a 24-hour period. After a single use, the patch must be discarded appropriately.

Once the pouch is opened, it should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use of this product is contraindicated in the following situations:

Application is prohibited on wounds, cuts, damaged, or infected skin due to the risk of exacerbating the condition. It should not be applied to the eyes, mouth, genitals, or any mucous membranes to prevent irritation or adverse reactions. Additionally, tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may lead to increased absorption and potential toxicity. Concurrent use with other topical analgesics is also contraindicated to avoid additive effects and potential overdose.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 800-222-1222.

Healthcare providers should monitor patients for any adverse reactions. Patients must be instructed to discontinue use and consult their physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, or any signs of skin injury, including pain, swelling, or blistering at the application site.

Additionally, it is recommended that pregnant or breastfeeding individuals consult a healthcare professional prior to using this product to ensure safety for both mother and child.

Side Effects

Patients should be aware that the product is intended for external use only. It is important to stop use and consult a healthcare professional if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using the product to ensure safety and appropriateness.

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 signs of irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical therapies.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may use this medication. For children under 12 years of age, consultation with a physician is advised prior to use.

It is important to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for the Rapid Relief Menthol Pain Patch. As such, healthcare providers may consider the standard dosing regimen for this population without the need for modifications based on age alone. However, it remains essential for providers to monitor elderly patients for any potential adverse effects, given the general increased sensitivity of this demographic to medications.

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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe 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 on 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 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 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 from an overdose. Symptoms 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Serious burns have been reported in rare cases associated with the use of products of this type. These events were documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed. Patients should be instructed to avoid applying the product on wounds, cuts, damaged, or infected skin, as well as on the eyes, mouth, genitals, or any other mucous membranes.

It is important for healthcare providers to inform patients to monitor their condition closely. They should be advised to report to their healthcare provider if their condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be made aware of signs of skin injury, such as pain, swelling, or blistering at the site of application, and to seek medical advice if these occur.

For patients who are pregnant or breastfeeding, healthcare providers should recommend consulting a health professional before use. Patients must be reminded to use the product only as directed and to be aware that rare cases of serious burns have been reported with similar products.

Additionally, healthcare providers should instruct patients not to bandage the area tightly or use a heating pad in conjunction with the product. It is crucial to avoid contact with the eyes and mucous membranes, and patients should be cautioned against applying the product to wounds or damaged skin. Finally, patients should be advised not to use this product simultaneously with other topical analgesics.

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 a temperature range of 15-30℃ (59-86℉) to maintain its efficacy. Additionally, the product should be kept out of reach of children to ensure safety. Proper handling and storage conditions are crucial for preserving the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended usage of one patch for up to 8 hours. Patients may repeat this application as necessary, but should not exceed three applications in a single day.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding prior to use. It is also crucial to advise patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)