Good Neighbor Pain Relief

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with various mouth and gum irritations, including toothache, sore gums, canker sores, discomfort from braces, minor dental procedures, and irritation from dentures.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area using a cotton ball, cotton swab, or fingertip. The application may be performed up to four times daily, or as directed by a healthcare professional.

In the case of children under 12 years of age, adult supervision is recommended during the use of this product to ensure safety and proper application.

For children under 2 years of age, it is advised to consult a doctor or dentist prior to use to determine the appropriateness of the product for this age group.

Contraindications

Use of this product is contraindicated in the following situations:

• Exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

• Use for more than 7 days is contraindicated unless directed by a healthcare professional, as prolonged use may lead to complications.

Warnings and Precautions

Patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. The potential for severe allergic reactions necessitates careful screening for such allergies prior to administration.

In the event of accidental ingestion of a quantity exceeding the recommended dosage for pain relief, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following conditions occur: sore mouth symptoms that do not show improvement within 7 days, persistent or worsening irritation, pain, or redness, or the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and intervention. Regular monitoring of these parameters is essential to ensure patient safety and effective management of any adverse reactions.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning is the allergy alert; individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, it is crucial to seek medical advice. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of adverse reactions.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, no additional monitoring or dosage adjustments are necessary regarding drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the product by applying the liquid with a cotton ball, cotton swab, or fingertip to the affected area up to four times daily, or as directed by a healthcare professional. For children under 12 years of age, adult supervision is recommended during use. In pediatric patients under 2 years of age, consultation with a doctor or dentist is advised prior to use.

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 safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants from the use of this product during lactation.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any symptoms observed, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the recommended amount of the product for pain relief. It is important to inform patients that they should discontinue use and consult a doctor or dentist if symptoms of a sore mouth do not improve within 7 days.

Healthcare providers should instruct patients to stop using the product and seek medical advice if they experience persistent or worsening irritation, pain, or redness. Additionally, patients should be made aware that they need to stop use and consult a healthcare professional if they develop swelling, a rash, or a fever.

Patients must be cautioned to avoid contact with their eyes while using this product. They should also be reminded not to exceed the recommended dosage and to refrain from using the product for more than 7 days unless specifically directed to do so by a doctor or dentist.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with specific instructions for application. Adults and children aged 2 years and older should apply the liquid using a cotton ball, cotton swab, or fingertip to the affected area up to four times daily, or as directed by a healthcare professional. For children under 12 years of age, adult supervision is recommended during use, while consultation with a doctor or dentist is advised for children under 2 years of age.

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

Drug Information (PDF)

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

View product document (PDF)