Eb301ct Bruise Pain Relief

Description

EB301CT is a pain-relieving spray formulated for the treatment of bruises. It is produced by Eminence Biotech and is available in a dosage form of 3.38 fluid ounces (100 mL). The product is identified by the National Drug Code (NDC) 53304-1301-1.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with bruises.

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

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 no more than 3 to 4 times daily.

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

Use of this product is contraindicated in the following situations:

The product should not be applied to the ears or nasal cavity due to potential adverse effects. It is contraindicated in pregnant individuals to avoid risks to fetal development. Application on wounds or damaged skin is prohibited to prevent exacerbation of the condition. Additionally, the product must not be used in any manner other than as directed to ensure safety and efficacy.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product on the ears or within the nasal cavity. Additionally, it should not be applied to wounds or damaged skin, and usage must strictly adhere to the directions provided.

During application, care should be taken to avoid contact with the eyes. In the event of accidental eye contact, it is essential to rinse the eyes thoroughly with water to mitigate any potential irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Furthermore, this product must 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 should be made 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. It is contraindicated for use during pregnancy, on wounds, or on damaged skin, and should only be used as directed.

While using this product, it is important to avoid contact with the eyes. In the event of contact, patients should rinse their eyes thoroughly with water.

Patients are advised to 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.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Eb301ct Bruise Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and adults 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 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 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 should not use this medication if they are pregnant. The potential for excretion of the drug in breast milk has not been addressed in the provided information. Therefore, healthcare professionals should exercise caution when considering this medication for lactating mothers, as the effects on breastfed infants are not specified.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 available in the provided data.

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.

Patients should be informed not to use the product in or around the ears or nasal cavity, and it should not be applied to wounds or damaged skin. It is essential to emphasize that the product should only be used as directed and not for any other purposes.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms improve and then recur within a few days.

While using the product, patients must be cautioned to avoid contact with the eyes. In the event of accidental eye contact, they should rinse their eyes thoroughly with water. Furthermore, it is important to inform patients that the product should not be used during pregnancy.

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 should be observed to prevent exposure to conditions that may compromise the product's quality.

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 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is advised prior to use.

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

Drug Information (PDF)

This file contains official product information for Eb301ct Bruise Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)