Thera Care Hot and Cold Medicated Patch

Description

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

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 applied 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. Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance or contact a Poison Control Center immediately.

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 stop use and consult a healthcare professional. These reactions warrant careful monitoring to ensure patient safety and effective management of any adverse effects.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Thera Care Hot and Cold Medicated Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should be evaluated by a physician prior to use. It is essential to consider the specific needs and conditions of this age group to ensure appropriate care and treatment.

Geriatric Use

There is no specific information regarding the use of Thera Care Hot and Cold Medicated Patch in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable when administering this product to the geriatric 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 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

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

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. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide management and ensure optimal patient outcomes.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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, patients must be made aware to avoid contact with their eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in pouches that must be resealed after opening to maintain integrity. It is essential to store the product at room temperature. Any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with adults and children over 12 years advised to wear one patch for up to 8 hours. This can be repeated as necessary, but should not exceed four applications in a 24-hour period.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or the use of heating pads in conjunction with the patch. Patients should be instructed to avoid contact with eyes and mucous membranes, and not to apply the patch to wounds or damaged skin. Additionally, pregnant or breastfeeding patients should consult a healthcare professional prior to use.

Drug Information (PDF)

This file contains official product information for Thera Care Hot and Cold Medicated Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)