Cool and Heat

Description

NDC 46122-743-27, GOOD NEIGHBOR PHARMACY® Maximum Strength Cool & Heat is a topical analgesic formulated with 16% menthol. This pain-relieving liquid is designed for rapid application using a roll-on applicator, ensuring a no-mess experience. The product dries quickly and is stain-free, available in a 2.5 fl oz (74 mL) bottle. Each package contains one bottle. This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Icy Hot®. It is distributed by AmerisourceBergen, located at 1 West First Ave, Conshohocken, PA 19428. For questions or concerns, visit www.mygnp.com. ABC#: 10274880.

Uses and Indications

This drug is indicated for the temporary relief of minor muscle and joint pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, and bruises.

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 application is to the affected area no more than 3 to 4 times daily. It is important to ensure that the medicine is applied as directed to maximize its effectiveness.

In the event that the medicine comes into contact with the hands, it is essential to wash the hands thoroughly with soap and water to prevent unintended exposure.

For children 12 years of age or younger, it is advised to consult a healthcare professional before use.

Contraindications

There are no specific contraindications listed for this product. However, it is 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, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging the treated area tightly or using it in conjunction with a heating pad. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin.

Patients may experience a temporary burning sensation following application; however, this typically resolves within several days. Should a severe burning sensation occur, the patient must discontinue use immediately. In the event of swelling or blistering of the skin, the patient should stop using the product and seek medical attention promptly.

It is crucial to instruct patients to avoid exposing the treated area to heat or direct sunlight to prevent exacerbation of any adverse effects.

General precautions include keeping the product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to stop using the product and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than seven days or resolve only to recur within a few days.

Emergency medical help should be sought if swelling or blistering of the skin occurs, necessitating immediate cessation of product use.

Side Effects

Patients using this product should be aware that it is for external use only and must be applied strictly as directed. It is important to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or to damaged, broken, or irritated skin.

A temporary burning sensation may occur following application; however, this sensation typically resolves within several days. Should a severe burning sensation arise, patients are advised to discontinue use immediately. In cases where swelling or blistering of the skin occurs, it is imperative to stop use and seek medical attention promptly.

Patients should also be instructed to stop using the product and consult a healthcare professional if any of the following conditions arise: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days. Additionally, treated areas should not be exposed to heat or direct sunlight to prevent further complications.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cool and Heat (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. For adolescents and children over 12 years, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, or safety concerns pertinent to this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual patient factors may influence treatment outcomes. Monitoring for efficacy and safety is advised, given the lack of targeted data for this demographic.

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 its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

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 kept away from fire or flame. Additionally, the product must be protected from light to maintain its integrity. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children over 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cool and Heat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)