Walgreens Cool and Heat

Description

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

Uses and Indications

This drug is indicated for the temporary alleviation of minor aches and pains associated with muscles and joints, including conditions such as arthritis, simple backache, strains, bruises, and 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 administration is to spray the product onto 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 before use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, tight binding of the product is not recommended, as it may lead to complications. The use of this product should not exceed one week to avoid potential risks associated with prolonged application.

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; hence, it must not be punctured or incinerated. Storage temperatures should not exceed 120°F.

Care should be taken to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, and it should not be used with tight bandages. It is essential 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, the user should discontinue use and consult a healthcare professional. The product should not be used for longer than one week.

In the event of accidental ingestion, immediate medical assistance should be sought, or the user should contact a Poison Control Center at 1-800-222-1222.

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 and precautions 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 is under pressure. Additionally, it should not be stored at temperatures exceeding 120°F.

When using this product, patients should avoid contact with the eyes and mucous membranes. It is contraindicated for application on wounds or damaged skin, and tight bandaging should be avoided. The product should be used only as directed.

Patients are advised to stop use and consult a doctor if their 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.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the Poison Control Center should be contacted at 1-800-222-1222. Pregnant or breastfeeding individuals should consult a health professional before use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Walgreens Cool and Heat (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use the spray product on the affected area, with a recommended application frequency of no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

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. 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 safe use during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 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. The national Poison Control Center can be reached at 1-800-222-1222.

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.

Management of overdosage may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to implement necessary interventions 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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the medication is swallowed.

Additionally, it is important for healthcare providers to counsel patients who are pregnant or breastfeeding to consult with a health professional prior to using this 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 near heat sources 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 must not be stored at temperatures above 120°F to maintain its integrity and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)