Signature Care Cold and Hot Medicated

Description

Signature Care Cold & Hot Medicated Patch is a topical formulation designed for the relief of minor aches and pains. The patch provides both cold and hot therapy, utilizing a dual-action mechanism to address discomfort. It is presented in a convenient adhesive patch form, allowing for easy application to affected areas. The product is intended for external use only and is suitable for various body parts.

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 due to arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to apply the patch to the affected area as needed, with a maximum frequency of four applications per day. For children under 12 years of age, it is recommended to consult a physician prior to use.

For optimal application, healthcare professionals should advise patients to partially peel back the protective film of the patch. The exposed adhesive side should be applied directly to the site of pain. After positioning the patch, the remaining protective film should be carefully removed while ensuring that the patch remains pressed against the skin.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with eyes or mucous membranes should be avoided due to the potential for irritation. Application to wounds, damaged skin, or very sensitive skin is contraindicated to prevent adverse reactions. Additionally, tight bandaging or the use of heating pads in conjunction with this product is not recommended, as it may exacerbate irritation or lead to other complications.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed to ensure safety and efficacy. It is imperative to avoid contact with the eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds, damaged skin, or areas of very sensitive skin to prevent further complications.

Patients should be cautioned against tightly bandaging the area of application or using the product in conjunction with a heating pad, as these practices may exacerbate irritation or lead to unwanted side effects.

In the event of excessive redness or irritation, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Furthermore, if pain persists for more than 7 days, or if symptoms resolve only to recur within a few days, medical advice should be sought.

It is essential to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or very sensitive areas, and it is advised not to bandage tightly or use in conjunction with a heating pad.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to place the patch on the affected area as needed, with a maximum frequency of four times daily.

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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if they experience excessive redness or irritation. Additionally, they should be informed to discontinue use and seek medical advice if their condition worsens or if pain persists for more than 7 days. It is also important to advise patients to stop using the product if symptoms resolve and then recur within a few days.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned to avoid contact with the eyes and mucous membranes. Furthermore, they should not apply the product to wounds, damaged skin, or very sensitive areas. Providers should also inform patients not to bandage the area tightly or use the product in conjunction with a heating pad.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should be applied to the affected area as needed, with a maximum frequency of four times daily. For children under 12 years of age, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)