Thera Care Cold Hot 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 aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort related to 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 three patches should be used in a single day. After use, the patch must be discarded, and the pouch should be resealed immediately after opening to maintain product integrity.

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:

• Infants: The safety and efficacy of this product have not been established in this population.

• Worsening condition: Discontinue use if the condition worsens.

• Presence of redness: Do not use if redness is observed.

• Development of irritation: If irritation occurs, discontinue use.

• Persistence of symptoms: If symptoms persist for more than 7 days or recur shortly after resolution, do not continue use.

• Signs of skin injury: Discontinue use if pain, swelling, or blistering occurs at the application site.

• Tight bandaging or heating pads: Avoid tight bandaging and do not use with heating pads.

• Contact with eyes and mucous membranes: Avoid application in these areas.

• Application to wounds or damaged skin: Do not apply to broken or damaged skin.

• Concurrent use with other topical analgesics: Avoid using simultaneously with other topical analgesics.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to minimize the risk of adverse effects. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar topical products.

It is imperative to avoid tight bandaging or the concurrent use of heating pads while using this product, as these practices may exacerbate the risk of burns. Additionally, contact with the eyes and mucous membranes must be strictly avoided. The product should not be applied to wounds or damaged skin, and it is contraindicated to use this product simultaneously with other topical analgesics.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare provider 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 resolution, or any signs of skin injury, including pain, swelling, or blistering at the application site.

Side Effects

For external use only. Patients should discontinue use and consult a doctor 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 occur again 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 any signs of increased local irritation or systemic effects is recommended if there is a need to transition between topical analgesics.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this product if they are infants. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted.

For children aged 12 years and older, the recommended application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8 hours, with a maximum of three applications per day. Each patch is for single use only and should be discarded after use, with the pouch resealed after opening.

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

Geriatric Use

There is no specific information regarding the use of Thera Care Cold Hot 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 this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before 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 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 to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use in infants. In the event of accidental ingestion, patients should seek medical assistance immediately or contact a Poison Control Center at 800-222-1222.

Patients should be instructed to use the product only as directed. They must be made aware that if their condition worsens, if redness develops, or if irritation occurs, they should discontinue use and consult a doctor. Additionally, if symptoms persist for more than 7 days, clear up and then recur within a few days, or if they experience signs of skin injury such as pain, swelling, or blistering at the application site, they should seek medical advice.

It is important to inform patients about the potential for rare but serious burns associated with products of this type. They should be cautioned against tightly bandaging the area of application or using a heating pad concurrently.

Patients must avoid contact with eyes and mucous membranes and should not apply the product to wounds or damaged skin. Furthermore, they should be advised not to use this product simultaneously with other topical analgesics to prevent 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 86°F (30°C). 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 Thera Care Cold Hot Medicated Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)