Natures Sunshine Products

Description

Everflex Topical Analgesic Pain Relief Cream is formulated with Methylsulfonylmethane (MSM) as an active ingredient. This topical analgesic is presented in a cream dosage form, packaged in a 2-ounce (57 grams) container. The product is designed for localized pain relief.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided. There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should evaluate the appropriateness of this drug based on individual patient needs and clinical judgment.

Dosage and Administration

Everflex should be massaged into the affected areas 3 to 4 times daily. It is important to ensure that the application is thorough, allowing for optimal absorption and relief of discomfort. Healthcare professionals should advise patients to use the product consistently for best results.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

The product is intended for external use only. It is imperative that healthcare professionals advise patients to avoid contact with the eyes to prevent potential irritation or injury.

Healthcare providers should ensure that patients are informed about the proper application techniques to minimize the risk of accidental eye contact. In the event of contact with the eyes, immediate rinsing with water is recommended, and if irritation persists, medical attention should be sought.

Monitoring for any adverse reactions following application is advised, particularly in patients with sensitive skin or a history of allergic reactions. Regular follow-up may be necessary to assess the patient's response to the treatment and to ensure safe usage.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation or injury. There are no additional specific adverse reactions reported in clinical trials or postmarketing experiences beyond these warnings. It is essential for patients to follow these guidelines to ensure safe and effective use of the product.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Natures Sunshine Products (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep the product out of reach of children. In cases where the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, the product should be discontinued, and a physician should be consulted.

The product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it is important to avoid tight bandaging of the area where the product is applied. Care should be taken to prevent contact with the eyes.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. Therefore, the safety of menthol during pregnancy has not been established. Pregnant patients are advised to consult a healthcare provider before using this product. There are no specific contraindications mentioned regarding its use during pregnancy, and no specific dosage modifications for pregnant individuals are provided. Caution is recommended, and healthcare professionals should consider the potential risks and benefits when advising women of childbearing potential.

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 regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

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 in a cool, dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The product is administered topically, with directions for use indicating that patients should massage Everflex into painful areas 3 to 4 times per day. Clinicians should advise patients to keep the product out of reach of children and to discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Patients should be cautioned against applying the product to wounds or damaged skin, bandaging tightly, and using it for anything other than external application. Additionally, contact with the eyes should be avoided.

Drug Information (PDF)

This file contains official product information for Natures Sunshine Products, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)