Eb301ap Pain Relief

Description

EB301AP is a pain-relieving spray formulated for topical application. The product is available in a dosage form of 3.38 fluid ounces (100 mL). It is identified by the National Drug Code (NDC) 53304-0301-1.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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:

Application on the ears or nasal cavity is prohibited due to potential adverse effects. The product should not be used during pregnancy, as it may pose risks to the developing fetus. Additionally, application on wounds or damaged skin is contraindicated to prevent further irritation or complications. Finally, the product must only be used as directed; any deviation from the specified instructions is not recommended.

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.

When utilizing this product, it is imperative 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 potential irritation.

Healthcare professionals should advise patients to discontinue use and seek medical advice 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 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 is recommended.

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 in pregnant individuals, on wounds or damaged skin, and should only be used as directed.

While using this product, patients must avoid contact with the eyes. In the event of eye contact, it is essential to rinse the 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.

This product should be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Eb301ap Pain 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 process may be repeated no more than 3 to 4 times daily.

It is essential to keep this 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 available 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. The potential risks associated with the use of this drug during pregnancy have not been established, and it is contraindicated in this population. Healthcare professionals are advised to consider alternative treatments for pregnant patients to avoid any potential adverse effects on fetal outcomes. Women of childbearing potential should be counseled regarding the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to lactating mothers. Further studies may be necessary to fully understand the implications of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 prescribing 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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. 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 on the ears or nasal cavity. Additionally, it is important to counsel patients against using the product if they are pregnant. They should also be cautioned not to apply the product on wounds or damaged skin and to use it only as directed.

Healthcare providers should encourage patients to stop using the product and consult a doctor if their condition worsens. Patients should also be advised to seek medical advice if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days.

Furthermore, when using this product, patients should be reminded 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 stability and efficacy. Proper handling should be observed to prevent exposure to conditions that may compromise the product's integrity.

Additional Clinical Information

The medication 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, 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 Eb301ap Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)