Healthwise Pain Relief

Description

No description information is available.

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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use. This precaution is essential to ensure safety and appropriateness of treatment for this age group.

Contraindications

The product should not be used in the following situations:

Tight bandaging is contraindicated as it may lead to compromised circulation. The application of a heating pad concurrently with the product is not recommended due to the potential for increased risk of burns or skin irritation. Puncturing or incinerating the product is contraindicated as it poses a risk of explosion or release of harmful substances. Additionally, storage at temperatures exceeding 120ºF is contraindicated to prevent degradation of the product and ensure 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 flame.

General precautions must be observed to ensure safe use. Care should be taken to avoid contact with the eyes; in the event of contact, the affected area should be flushed thoroughly with water. Additionally, contact with broken skin should be avoided. Bandaging should not be applied tightly, and the product should not be used in conjunction with a heating pad. The contents are under pressure; thus, puncturing or incinerating the container is strictly prohibited. It is also essential to store the product at temperatures not exceeding 120ºF.

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

Healthcare professionals should advise patients to discontinue use and consult a physician 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. No specific laboratory tests are recommended for monitoring during the use of this product.

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. Users are advised to keep the product out of the eyes, and in the event of contact, they 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 users must not 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 7 days, or if it clears up and recurs within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

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 the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

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

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation of each patient's unique circumstances.

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. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: rash, irritation, and other unspecified reactions. These events were documented in the context of routine pharmacovigilance activities.

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 recurs within a few days.

When using the 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 applying the product to 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 instructed to store the product at temperatures not exceeding 120ºF to ensure safety and efficacy.

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 Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)