Cool and Heat

Description

The product is identified by the SPL Code 34089-3. No specific description details are provided in the text.

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 before use. For adults and children aged 12 years and older, the recommended administration is to spray the product on the affected area, not exceeding 3 to 4 times daily. For children under 12 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or near heat or flame. Long-term storage above 104°F should be avoided, and the product must not be punctured or incinerated, as it contains contents under pressure. Additionally, it should not be stored at temperatures exceeding 120°F.

General precautions include avoiding contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and tight bandaging is not recommended. It is imperative to use the product only as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to stop use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. If the product is needed for longer than one week, consultation with a healthcare provider is necessary.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before use to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging the area tightly and should use the product only as directed.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. If the product is needed for longer than one week, medical advice should also be sought.

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

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use.

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 Cool and Heat (menthol 16%). 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 spray on the affected area no more than 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 question.

Postmarketing Experience

No postmarketing experience details have been reported for SPL code 90375-7.

Patient Counseling

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

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be cautioned against using the product for longer than one week without medical advice.

While using this product, patients must be reminded to avoid contact with eyes and mucous membranes. They should also be instructed not to apply the product to wounds or damaged skin and to refrain from tightly bandaging the area where the product is applied. It is essential that patients use the product only as directed to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product in a controlled environment, avoiding long-term storage at temperatures exceeding 104°F. Additionally, the product must not be stored at temperatures above 120°F to maintain its integrity and efficacy.

Care should be taken to ensure that the container remains intact; puncturing or incinerating the container is strictly prohibited, as the contents are under pressure. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

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 before using the product. 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)