Cool and Heat Pain Relieving Liquid

Description

Menthol 16% is a topical analgesic formulated for external use. It is presented in a convenient roll-on applicator, designed to provide a no-mess application. The formulation dries rapidly upon application and is designed to be stain-free. Each container holds 2.5 fluid ounces (74 mL) of the product.

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 hands, it is essential to wash the hands thoroughly with soap and water to prevent unintended exposure or ingestion.

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

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is not recommended, as it may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Application to wounds or damaged, broken, or irritated skin is contraindicated due to the potential for exacerbating the condition. Additionally, exposure of the treated area to heat or direct sunlight is not advised, as it may compromise the efficacy of the product and increase the risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against tightly bandaging the treated area 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, which typically resolves within several days. However, if a severe burning sensation occurs, the patient should discontinue use immediately. In cases where swelling or blistering of the skin is observed, it is essential to stop use and seek medical attention promptly. Additionally, patients should be cautioned against exposing the treated area to heat or direct sunlight, as this may exacerbate adverse effects.

This product is flammable; therefore, it should be kept away from fire or flame.

Patients should be instructed to stop use 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 7 days or resolve only to recur within a few days.

In the event of ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

General precautions should be taken for pregnant or breastfeeding individuals; they are advised to consult a healthcare professional prior to use.

Side Effects

Patients may experience a range of adverse reactions following the use of this product. A temporary burning sensation is commonly reported and typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, if swelling or blistering of the skin is observed, it is crucial to stop use and seek medical attention promptly.

Patients should be vigilant for signs that warrant discontinuation of use and consultation with a healthcare provider. These include worsening of the condition, the presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

It is important to note that the product is flammable; therefore, patients should keep it away from fire or flame. Furthermore, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended. Pregnant or breastfeeding patients should consult a healthcare professional prior to use to ensure safety.

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 Cool and Heat Pain Relieving Liquid (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. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 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 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. A temporary burning sensation may occur following application; however, this typically resolves within several days. In the event of a severe burning sensation, it is recommended to discontinue use immediately. Should swelling or blistering of the skin occur, it is important to stop use and seek medical attention.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data from animal pharmacology and toxicology studies.

Postmarketing Experience

A temporary burning sensation has been reported following the use of the product; this sensation typically resolves within several days. In cases where a severe burning sensation occurs, it is advised to discontinue use immediately. Additionally, reports of swelling or blistering of the skin have been noted; in such instances, it is recommended to stop use and seek medical attention.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days or clear up and recur within a few days.

It is important to emphasize that this product is for external use only. When using the product, patients should be reminded to use it only as directed. They should avoid bandaging the area tightly or using it in conjunction with a heating pad. Additionally, patients should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged, broken, or irritated skin.

Patients may experience a temporary burning sensation after application, which typically resolves within several days. However, if a severe burning sensation occurs, they should discontinue use immediately. In cases of swelling or blistering of the skin, patients should stop using the product and seek medical attention.

Finally, patients should be advised to avoid exposing the treated area to heat or direct sunlight.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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