Menthol

Description

Cool 'n Heat is a pain-relieving spray formulated with 16% menthol. The product is designed to provide a dual sensation of cooling and heating upon application. It is presented in a spray dosage form, allowing for targeted delivery to affected areas. The effective time for this formulation is noted as November 9, 2018. The product is visually represented in an image/jpeg format, with the reference number 6071-WG-US-Rev1-Cool-n-heat.jpg.

Uses and Indications

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

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

Dosage and Administration

The product should be shaken well prior to use. For adults and children aged 12 years and older, the recommended dosage is to spray on the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor before administration.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding unless directed by a healthcare professional.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or flames. Long-term storage above 104°F is not recommended. The container is under pressure; do not puncture or incinerate. It is essential to avoid storing the product at temperatures exceeding 120°F.

When using this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it should not be bandaged tightly. It is imperative to use the product only as directed.

Users should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The product should not be used for longer than one week.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center.

For individuals who are pregnant or breastfeeding, it is advisable to consult a healthcare professional prior to use.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flames. Long-term storage above 104°F should be avoided, and the product should not be punctured or incinerated, as it contains contents under pressure. Additionally, it is crucial to store the product at temperatures not exceeding 120°F.

While using this product, patients should avoid contact with the eyes and mucous membranes. It should not be applied to wounds or damaged skin, and tight bandaging should be avoided. Patients are advised to use the product only as directed. If the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should stop use and consult a healthcare professional. The product should not be used for longer than one week.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center should be made. Pregnant or breastfeeding patients are advised to consult a healthcare professional before use.

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 N Heat. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents aged 12 years and older, the recommended dosage is to spray the product on the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother 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 mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be guided by the clinical presentation and may include supportive care and symptomatic treatment. Healthcare providers are encouraged to follow established protocols for the management of overdose cases, which may involve monitoring vital signs, providing respiratory support, and administering specific antidotes if applicable.

In all cases of suspected overdosage, the involvement of a medical professional is crucial to ensure appropriate care and to mitigate potential complications.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should emphasize the importance of consulting a health professional if the patient is pregnant or breastfeeding before using the medication. This ensures that patients receive appropriate guidance regarding the safety and potential risks associated with the use of the medication during these critical periods.

Storage and Handling

The product is supplied in a pressurized container, which must not be punctured or incinerated. It is essential to handle the product with care, as it is flammable; therefore, it should not be used while smoking or in proximity to heat or flames.

For optimal storage, the product should be kept in a cool, dry place. Long-term storage should be avoided at temperatures exceeding 104°F, and it is critical not to store the product at temperatures above 120°F to maintain its integrity and safety.

Additional Clinical Information

The product is administered topically, with a recommended frequency of application for adults and children aged 12 years and older being 3 to 4 times daily on the affected area. For children under 12 years of age, it is advised to consult a healthcare professional prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)