Qc Cold and Hot Pain Relief

Description

QC Cold and Hot Patch is a therapeutic device designed for the application of cold or heat therapy. It is formulated to provide relief from pain and discomfort associated with various conditions. The patch is composed of a flexible material that conforms to the body, ensuring effective contact with the skin. The product is intended for single use and is packaged in a manner that maintains its integrity until application.

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, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended administration involves the careful removal of the backing from the patch. One patch should be applied to the affected area. This application may be repeated as necessary, but should not exceed four times daily.

For children aged 12 years or younger, it is advised to consult a physician prior to use.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may lead to adverse effects. Additionally, application to wounds, damaged skin, or areas of broken or irritated skin is not recommended due to the potential for increased irritation or complications.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes, as this may lead to adverse effects. Additionally, patients should be cautioned against tightly bandaging the area of application or using a heating pad concurrently, as these practices may exacerbate potential side effects.

The product should not be applied to wounds, damaged skin, or areas that are broken or irritated. In the event that the patient's condition worsens, or if redness or irritation develops, it is essential to discontinue use and consult a healthcare provider. Patients should also be instructed to seek medical advice if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product only as directed and to avoid contact with the eyes and mucous membranes. Patients are advised not to bandage tightly or use the product in conjunction with a heating pad. Additionally, the product should not be applied to wounds, damaged skin, or broken or irritated skin.

In the event that the condition worsens, redness appears, irritation develops, or symptoms persist for more than 7 days or clear up and then recur within a few days, patients should stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional before using this product.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 question.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if any redness appears, or if irritation develops. Patients should also be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up 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 during application. Additionally, it is crucial to inform patients not to bandage the area tightly or use the product in conjunction with a heating pad. They should also be advised against applying the product to wounds, damaged skin, or any areas that are broken or irritated.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, one patch should be applied to the affected area, with the option to repeat this application as necessary, not exceeding four times daily. For children aged 12 years or younger, 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 Qc Cold and Hot Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)