Theracare 5% Menthol Pain Relief Patch

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal 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, but the maximum allowable usage is three patches per day. Each patch is for single use only and should be discarded after application. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

For children under 12 years of age, consultation with a physician is recommended prior to use.

Contraindications

Use is contraindicated in the following situations:

• Application on infants is not recommended due to the potential for adverse effects.

• Tight bandaging or concurrent use with heating pads is contraindicated to prevent skin irritation or injury.

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

• Application to wounds or damaged skin is contraindicated to avoid exacerbating the condition or causing further harm.

• Concurrent use with other topical analgesics is not advised to prevent potential interactions or increased risk of side effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to discontinue use and seek medical consultation under the following circumstances: if the condition worsens; if redness or irritation develops; if symptoms persist for more than 7 days or resolve only to recur within a few days; or if any signs of skin injury, such as pain, swelling, or blistering at the application site, are observed.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if redness is present, or if irritation develops. Additionally, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought. Patients should also seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

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

Packaging & NDC

Below are the non-prescription pack sizes of Theracare 5% Menthol Pain Relief Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this product without consulting a physician. It is important to keep the product out of reach of children. The product is contraindicated for infants; if ingested, immediate medical assistance should be sought or contact a Poison Control Center at 1-800-222-1222.

For adolescents aged 12 years and older, the recommended 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 in an 8-hour period, with a maximum of three patches allowed per day. Each patch is for single use only and should be discarded after application. The pouch should be resealed after opening to maintain product integrity.

Geriatric Use

There is no specific information regarding the use of Theracare 5% Menthol Pain Relief Patch in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering this product for elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs and responses. It is advisable to evaluate the overall health status and any concurrent medications of geriatric patients prior to recommending the use of this patch.

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 known. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 compound in these areas.

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 help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to monitor their condition closely. They should seek medical attention if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days. Additionally, patients should be aware that if symptoms clear up and then recur within a few days, they should consult their healthcare provider. Signs of skin injury, such as pain, swelling, or blistering at the application site, should also prompt immediate medical consultation.

It is essential to instruct patients to use the product only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. Patients should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes. Patients should not apply the product to wounds or damaged skin. Furthermore, it is crucial to inform patients not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

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, ensuring that the temperature does not exceed 86ºF (30ºC). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Theracare 5% Menthol Pain Relief Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)