Walgreen Cool N Heat Maximum Strength Pain Relieving

Description

This formulation contains 16% menthol as the active ingredient, designed for pain relief. It is presented in a liquid dosage form, with a total volume of 2.5 fluid ounces (73 mL). The product is intended for topical application to alleviate discomfort.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication generously to the affected area. The application should be followed by massaging the product into the painful area until it is thoroughly absorbed into the skin. This process may be repeated if necessary, but should not exceed 3 to 4 times daily. In the event that the medicine comes into contact with hands, it is essential to wash hands with soap and water immediately.

For children under 12 years of age, it is advised to consult a doctor prior to 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 bandaging is not recommended, as it may compromise circulation. The use of heating pads or other heating devices in conjunction with this product is also contraindicated, as it may lead to increased risk of irritation or burns.

Warnings and Precautions

For external use only, this product should be tested on a small patch of skin prior to generous application to ensure no adverse reactions occur. It is imperative that the product is used strictly as directed to minimize the risk of complications.

Contact with the eyes and mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, it is advised not to bandage the area tightly after application, nor should it be used in conjunction with heating pads or other heating devices, as this may increase the risk of skin irritation.

In the event of redness or skin irritation, the use of the product should be discontinued immediately, and a healthcare professional should be consulted. Users may experience a transient burning sensation upon application; however, this typically resolves within several days. Should the condition worsen, or if symptoms persist for more than 7 days or recur shortly after resolution, it is essential to stop use and seek medical advice.

This product must 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 is recommended.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and it is recommended that patients perform a patch test on a small area of skin prior to generous application.

During use, if patients experience redness or skin irritation, they should discontinue use immediately and consult a healthcare professional. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days.

Patients are advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, the product is flammable, and patients should keep it away from fire or flame. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreen Cool N Heat Maximum Strength Pain Relieving (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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. 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 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is crucial 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 essential.

Management of overdosage 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 management of any complications that may arise.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. A transient burning sensation may occur upon application; however, this effect generally resolves within several days. No relevant information is available 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 this product out of reach of children. 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 stop using the product 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.

When using this product, patients must use it only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. It is important to advise patients against bandaging the area tightly and to refrain from using heating pads or other heating devices in conjunction with the product.

Patients should be made aware that if redness is present, they should discontinue use and consult a doctor. Additionally, if skin irritation occurs, they should stop using the product. A transient burning sensation may occur upon application; however, this sensation generally disappears within several days.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients should apply the medication generously to the affected area and massage it into the skin until thoroughly absorbed. This application may be repeated if necessary, but should not exceed 3 to 4 times daily.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. Additionally, it is important to keep the product out of reach of children; if swallowed, medical assistance should be sought or a Poison Control Center contacted immediately.

Drug Information (PDF)

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

View product document (PDF)