Eb302 Arthritis Relief

Description

EB302 is a product developed by Eminence Biotech, specifically formulated as an arthritis relief spray. It is presented in a dosage form of 1.69 fluid ounces (50 mL). The product is identified by the National Drug Code (NDC) 53304-03021.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with arthritis. It is intended for use in patients experiencing discomfort related to these conditions.

Dosage and Administration

For adults and children aged 12 years and over, the recommended administration involves spraying a sufficient amount of the product onto the affected area to ensure complete coverage. The area should then be gently rubbed until dry. This application may be repeated up to three times daily, as needed.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated for use in the following situations:

Application on the ears or nasal cavity is prohibited due to potential adverse effects. Use is contraindicated in pregnant individuals to avoid risks to fetal development. The product should not be applied to wounds or damaged skin, as this may exacerbate injury or lead to infection. Additionally, use must strictly adhere to the provided directions; any deviation from these instructions is contraindicated.

This product is intended for external use only.

Warnings and Precautions

For external use only, this product is contraindicated for application on the ears or nasal cavity, during pregnancy, on wounds or damaged skin, and should only be used as directed.

Healthcare professionals should advise patients to avoid contact with the eyes while using this product. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water to mitigate potential irritation.

Patients are instructed to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

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

Side Effects

Patients should be aware that this product is for external use only and should not be applied to the ears or nasal cavity, on wounds or damaged skin, or used in any manner other than as directed. It is contraindicated for use during pregnancy.

While using this product, patients are advised to avoid contact with the eyes. In the event of accidental eye contact, it is important to rinse the eyes thoroughly with water.

Patients should discontinue use and consult a healthcare professional if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product should be kept out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Eb302 Arthritis Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the recommended application involves spraying a sufficient amount onto the affected area to ensure complete coverage, followed by rubbing until dry. This application may be repeated no more than three times daily.

It is essential to keep the 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 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 should not use this medication due to potential risks to fetal health. The available data indicate that the use of this medication during pregnancy may pose significant risks, and therefore, it is contraindicated in this population. Healthcare professionals are advised to counsel women of childbearing potential regarding the importance of effective contraception during treatment and to discuss the potential risks associated with unintentional exposure during pregnancy.

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. There is no available data regarding the excretion of this product in human breast milk or its effects on breastfed infants. Due to the lack of information, caution is recommended when considering the use of this product during lactation. Additionally, this product is contraindicated in pregnant individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant individuals due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to emphasize that this product is for external use only and should not be applied to the ears or nasal cavity. Patients should be informed that the product should not be used if they are pregnant, and it should not be applied to wounds or damaged skin.

Healthcare providers should remind patients to use the product only as directed and to discontinue use and consult a doctor if their condition worsens. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using this product, patients should be cautioned to avoid contact with the eyes. In the event of eye contact, they should rinse their eyes thoroughly with water.

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 place, maintaining room temperature, and to keep it away from heat and light sources to ensure its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, a sufficient amount should be sprayed onto the affected area to ensure complete coverage, followed by rubbing until dry. This process may be repeated no more than three times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Eb302 Arthritis Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)