Healthwise Cooling Pain Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor 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 aged 2 years or older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a physician before use.

Contraindications

The product should not be used in the following situations:

Tight bandaging is contraindicated as it may compromise circulation. The application of a heating pad in conjunction with this product is not recommended due to the potential for increased skin irritation or burns. Puncturing or incinerating the product is contraindicated to prevent hazardous situations. Additionally, storage at temperatures exceeding 120ºF is prohibited to maintain product integrity and safety.

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 open flames.

General precautions must be observed to ensure safe use. Care should be taken to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to flush the eyes thoroughly with water. Additionally, contact with broken skin should be avoided, and the product should not be applied with a tight bandage. The use of heating pads in conjunction with this product is contraindicated. The contents are under pressure; thus, puncturing or incinerating the container is strictly prohibited. Furthermore, it should not be stored at temperatures exceeding 120ºF.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, or if a rash or irritation develops that persists for more than 7 days, or if it resolves and recurs within a few days.

In case of ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. It is crucial to keep the product out of the eyes, and in the event of contact, patients should flush the eyes thoroughly with water. Additionally, contact with broken skin should be avoided, and the product should not be bandaged tightly or used in conjunction with a heating pad. The contents are under pressure, and patients are advised not to puncture or incinerate the container, nor store it at temperatures exceeding 120ºF.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, or if a rash or irritation develops that lasts for more than seven days, or if it clears up and recurs within a few days. It is also essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Healthwise Cooling Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety in pregnancy, and therefore, its use in pregnant patients should be approached with caution. There are no specific contraindications listed for use during pregnancy; however, the safety of menthol during this period has not been established. It is recommended that pregnant women consult a healthcare provider before using this product to discuss potential risks and benefits. No specific dosage modifications for pregnant individuals are provided, but special precautions should be taken to ensure the health and safety of both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 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.

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 without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients to discontinue use and consult a healthcare provider if their condition worsens.

Patients should also be informed to stop using the product and seek medical advice if they experience a rash or irritation that persists for more than 7 days, or if the rash clears up and then reoccurs within a few days.

When using this product, patients must be cautioned to avoid contact with the eyes. In the event of eye contact, they should flush the eyes thoroughly with water. Additionally, patients should be advised to avoid contact with broken skin and to refrain from bandaging the area tightly.

Patients should not use the product in conjunction with a heating pad. It is essential to inform them that the contents are under pressure, and they should not puncture or incinerate the container. Furthermore, patients should be warned against storing the product at temperatures exceeding 120ºF.

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 out of direct sunlight, in a cool, dry, and well-ventilated area to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains stable and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Healthwise Cooling Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)