Evel Knievels Natural Choice Pain Relief

Description

Evel Knievel's 1 Natural Choice™ Pain Relief Gel is a topical formulation designed for pain relief. The product has been available since 1995 and is presented in a net weight of 3 ounces (85 grams).

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, strains, sprains, and joint pain.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to roll the product onto the affected area no more than 3 to 4 times daily. Prior to use, it is essential to shake the container well to ensure proper mixing of the formulation.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with heating pads or devices, as this may lead to adverse effects. Additionally, the product should not be applied alongside ointments, creams, sprays, or liniments due to potential interactions that could compromise efficacy or safety. It is also contraindicated for use on wounds, damaged skin, or irritated skin, as this may exacerbate the condition or lead to further complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals are advised to counsel patients to consult a physician prior to use if they have sensitive skin or are pregnant or breastfeeding. These considerations are essential to ensure the safety and appropriateness of the product for individual patients.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. Additionally, if any irritation develops, it is imperative to stop use and seek medical advice.

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 be kept away from excessive heat or open flame. It is contraindicated for use with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Additionally, it should not be applied to wounds, damaged skin, or irritated skin.

Before using this product, patients are advised to consult a healthcare professional if they have sensitive skin or are pregnant or breastfeeding. While using the product, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. Development of irritation is also a reason to stop use and consult a healthcare provider.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Co-administration with these products may lead to adverse effects or diminished therapeutic efficacy.

There are no specific laboratory test interactions reported for this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Evel Knievels Natural Choice Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years old should consult a physician prior to use. For children aged 2 years and older, the recommended application is to roll on the affected area no more than 3 to 4 times daily.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. 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 considering the use of this medication during lactation.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 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

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

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is crucial to emphasize the importance of acting quickly in such situations to ensure patient safety.

Patients should be informed to avoid any contact with the eyes or mucous membranes, as this could lead to irritation or other adverse effects. Clear instructions on how to handle the medication safely should be provided to minimize the risk of accidental exposure.

Additionally, healthcare providers should instruct patients not to bandage the area tightly. This precaution helps prevent complications and ensures proper circulation, promoting better healing outcomes.

Storage and Handling

The product is supplied with specific handling and storage requirements to ensure its integrity and efficacy. After each use, it is essential to replace the cap to maintain the product's quality.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and moisture. These conditions will help preserve the product's stability and effectiveness throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)