Signature Care Medicated Cold and Hot Patch

Description

Signature Care Medicated Cold & Hot Patch is designed for therapeutic use, providing both cold and hot relief. The product is effective as of November 1, 2023. It is presented in a visual format, specifically as an image/jpeg file, which is referenced by the filename 92-58009 1023 BOX Cold Hot.jpg.

Uses and Indications

This drug is indicated for the temporary relief of minor muscle and joint pain. It is intended for use in adults and children as directed.

Dosage and Administration

Adults and children 12 years of age and over should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Only one patch should be used at a time. The patch may be reapplied as necessary, but the total number of applications must not exceed three times daily. After a single use, the patch must be discarded properly.

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 advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Infants should not be treated with this product due to the potential for adverse effects.

Additionally, the product should not be applied in the following circumstances:

• Do not bandage tightly or use in conjunction with a heating pad, as this may increase the risk of skin irritation or burns.

• Avoid contact with eyes and mucous membranes to prevent irritation or injury.

• Do not apply to wounds or damaged skin, as this may exacerbate the condition or lead to systemic absorption.

• Concurrent use with other topical analgesics is contraindicated to avoid potential additive effects and increased risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid tight bandaging and the concurrent use of heating pads, as these practices may exacerbate the risk of adverse effects. Additionally, contact with the eyes and mucous membranes should be strictly avoided, and the product must not be applied to wounds or damaged skin. The simultaneous use of other topical analgesics is contraindicated.

Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, the presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate consultation with a healthcare professional.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of adhering to the recommended usage guidelines. It is advised not to bandage the area tightly or use the product in conjunction with a heating pad, as these practices may increase the risk of adverse reactions.

Participants should avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is not recommended, as this may lead to increased risk of adverse effects.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

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 any signs of increased irritation or adverse reactions is recommended if there is a need for analgesic therapy.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. The product is not recommended for infants. It is essential to keep the product out of reach of children. In the event of accidental ingestion, 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 application involves carefully removing the backing from the patch and applying the sticky side to the affected area. Only one patch should be used at a time, with a maximum of three applications per day. Each patch is for single use only and should be discarded after application.

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. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this 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 before initiating treatment.

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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 the compound's potential effects in these areas.

Postmarketing Experience

Rare cases of serious burns have been reported in postmarketing experience with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to avoid using it on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must use it only as directed. It is important to inform them 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. They should also avoid contact with the eyes and mucous membranes, refrain from applying the product to wounds or damaged skin, and not use it 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 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 Signature Care Medicated Cold and Hot Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)