Gumnumb Topical Anesthetic

Description

Gum Numb Grape is identified by the SPL code 34089-3. The product is presented in a formulation designed for oral use, characterized by its grape flavor. The specific appearance is represented in the associated image file, "Gum Numb Grape Rev 7 OL_newnumber.jpg." Further details regarding the chemical composition and inactive ingredients are not provided in the extracted facts.

Uses and Indications

This drug is indicated for oral mucosa use only, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

Limitations of use include the restriction to oral mucosa application and the necessity for administration under the guidance of a dental professional. There are no teratogenic or nonteratogenic effects reported.

Dosage and Administration

The recommended dosage involves applying the necessary amount of the product directly to the oral mucosa to effectively prevent or relieve pain.

It is important to note that this product is not indicated for use in children under 2 years of age. Healthcare professionals should ensure that this guideline is strictly followed to ensure patient safety.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This risk exists even in individuals who have previously used the product without issue. Healthcare professionals should advise patients to discontinue use and seek immediate medical attention if they or a child in their care exhibit any of the following symptoms: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product due to the risk of severe allergic reactions.

The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, patients should be advised to consult their physician promptly. Additionally, this product is contraindicated for teething and should not be administered to children under 2 years of age.

While using this product, it is essential to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed with water immediately.

Patients must not exceed the recommended dosage. In cases where more than the advised amount is ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

For individuals who are pregnant or breastfeeding, it is crucial to consult a physician prior to use to ensure safety for both the mother and child.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be vigilant for symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy. Immediate medical attention is required if any of these symptoms develop, regardless of prior use of the product.

Patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid using this product due to the risk of allergic reactions.

The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients are advised to consult their physician promptly. Additionally, the product is contraindicated for use in teething and in children under 2 years of age.

While using this product, patients should avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is also crucial not to exceed the recommended dosage. If more than the recommended amount is accidentally ingested, medical help or contact with a Poison Control Center should be sought without delay.

For pregnant or breastfeeding patients, it is recommended to consult a physician before use to ensure safety.

Drug Interactions

Patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product due to the risk of allergic reactions.

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in patients who have previously used the product without incident. Prompt treatment is essential if methemoglobinemia is suspected. Monitoring for signs and symptoms of this condition is advised, particularly in patients with risk factors or those receiving higher doses.

Packaging & NDC

Below are the non-prescription pack sizes of Gumnumb Topical Anesthetic (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. Caution is advised due to the risk of methemoglobinemia; caregivers must be vigilant for symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy. If any of these symptoms occur, immediate medical attention should be sought. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for healthcare providers to evaluate the individual circumstances of women of childbearing potential when prescribing this medication.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when recommending this medication to lactating patients.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Healthcare professionals should emphasize the importance of not exceeding the prescribed amount.

Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is necessary. It is advised to contact a Poison Control Center or seek emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

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

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

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 unintentional exposure in young children. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its accessibility.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 59° to 86°F (15° to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. Additionally, it is important to keep the product out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Gumnumb Topical Anesthetic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)