Thera Care Pain Relief Menthol Patchs

Description

Veridian Healthcare, LLC, located in Gurnee, IL 60031, is the manufacturer of this product. For inquiries, a toll-free customer care help line is available Monday through Friday from 8:30 am to 4:30 pm CST at 866-326-1313. The product is visually represented by the label image titled "patchimage.jpg."

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 over 12 years of age should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than 4 patches should be used in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

For children 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects. Additionally, contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. The application of this product to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging tightly or using the product in conjunction with a heating pad, as this may lead to adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, as exposure can result in irritation or injury. Additionally, the product must not be applied to wounds or damaged skin to avoid complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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, development of irritation, or if symptoms persist beyond 7 days or reappear shortly after resolution. Monitoring for these signs is crucial to ensure patient safety and effective management of their condition.

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, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to discontinue use and consult a healthcare professional. These precautions are essential to ensure the safety and well-being of patients using the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

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.

Due to the lack of data, it is advisable to closely monitor elderly patients for any adverse effects or changes in efficacy. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this treatment in the geriatric population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before 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 prior to use to ensure appropriate management and consideration of any potential risks.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact Poison Control if the product is swallowed. It is important to inform patients that they should monitor their condition closely and report to their healthcare provider if any of the following occur: worsening of their condition, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Patients should be instructed to use the product strictly as directed. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, and they should advise patients not to apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a resealable pouch, which should be securely resealed after each use to maintain product integrity. It is essential to keep the product out of reach of children to ensure safety during storage and handling.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, the patch should be applied to the affected area by carefully removing the backing and placing the sticky side onto the skin. Each patch can be worn for up to 8 hours, with a maximum of 4 applications per day. For children aged 12 years or younger, consultation with a physician is advised prior to use.

Clinicians should counsel patients to use the medication only as directed. Patients are advised not to bandage the area tightly or use a heating pad in conjunction with the patch. It is important to avoid contact with eyes and mucous membranes, and the patch should not be applied to wounds or damaged skin. Patients should discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist for more than 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)