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Gingicaine Fusion

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 7, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 7, 2021
Manufacturer
Gingi-Pak a Division of the Belport
Registration number
part356
NDC roots
10129-040, 10129-041
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You may be looking for information about a specific medication, but unfortunately, no drug name or details about its purpose and use were provided in the information available. Typically, medications are designed to treat specific conditions or symptoms, and they may work by targeting certain processes in the body. If you have a particular drug in mind, please provide its name or any additional details, and I would be happy to help you understand what it is and how it may be used.

Uses

It appears that there are no specific uses or indications provided for this medication. This means that the information regarding what conditions or symptoms the drug is intended to treat is not available. Additionally, there are no details about any potential teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development) mentioned in the text.

If you have any questions or need further information about this medication, it’s best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

It seems that there are no specific details provided regarding the dosage, administration, route, method, or frequency for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or apply the medication safely and effectively. They will be able to give you the necessary guidance based on your individual health needs. Always follow their recommendations to ensure the best outcomes for your treatment.

What to Avoid

It's important to be aware of certain precautions when considering this medication. If you have a known allergy to any of its components, you should not take or use it. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always consult with your healthcare provider if you have any questions or concerns about your health and medication use. Your safety is the top priority, so make sure to discuss any allergies or previous reactions to medications with your doctor.

Side Effects

It seems that the provided bullet list does not contain specific side effects or adverse reactions. Therefore, I cannot provide a summary of side effects, warnings, or contraindications based on the information given. If you have more detailed information regarding side effects or any other relevant data, please share it, and I would be happy to help you convert that into clear, consumer-friendly language.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. While there are no specific warnings or general precautions listed, you should always monitor how you feel while taking any medication. If you experience any unusual symptoms or side effects, it's best to stop taking the medication and consult your doctor for guidance.

Additionally, if you ever feel that you need immediate medical assistance, don't hesitate to seek emergency help. Always prioritize your health and safety by staying informed and proactive about your treatment.

Overdose

If you suspect an overdose, it’s important to act quickly. Signs of an overdose can include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help or call emergency services.

In the event of an overdose, do not wait for symptoms to worsen. Contact a healthcare professional right away for guidance on what to do next. Remember, your safety is the top priority, and timely intervention can make a significant difference.

Pregnancy Use

It’s important to be cautious when considering the use of GINGICAINE FUSION (benzocaine gel) during pregnancy. The safety of this product for pregnant individuals has not been established, meaning that there is not enough information to confirm it is safe for you or your developing baby.

Due to potential risks to the fetus, it is advised that you avoid using this product while pregnant. Always consult with your healthcare provider for guidance on safe treatment options during pregnancy.

Lactation Use

If you are breastfeeding, it's important to know that there are no specific warnings or recommendations about using GINGICAINE FUSION while nursing. Currently, there is also no information available regarding whether this medication is passed into breast milk or if it poses any risk to your infant.

As always, if you have concerns or questions about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about the use of GINGICAINE FUSION (benzocaine gel) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider.

Before starting treatment and throughout your therapy, your renal function will be assessed through tests. If you have significant renal impairment, a lower dose of the medication is recommended to ensure your safety and effectiveness of the treatment. Always communicate with your healthcare team about your kidney health to receive the best care possible.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance and safety of your product, it's important to store it in a cool, dry place. Avoid exposing it to excessive heat, as this can damage the device and affect its effectiveness.

When handling the product, make sure to follow any specific instructions provided to maintain its integrity. Proper storage and careful handling will help you use the device safely and effectively.

Additional Information

No further information is available.

FAQ

What should I do if I have an allergy to this product?

You should not use this product if you have an allergy, although specific details are not provided.

Is GINGICAINE FUSION safe to use during pregnancy?

The safety of GINGICAINE FUSION (benzocaine gel) during pregnancy has not been established, and its use is contraindicated in pregnant women due to potential risks to the fetus.

What precautions should I take regarding children?

Keep this product out of reach of children.

Are there any specific instructions for use?

Refer to the image 'Directions.jpg' for detailed directions on how to use the product.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and you should be closely monitored.

Is there any information about nursing mothers using this product?

There are no specific warnings or recommendations regarding the use of GINGICAINE FUSION in nursing mothers.

What should I do in case of an overdose?

Specific instructions for overdosage are not provided, but you should consult a doctor immediately.

Are there any known drug interactions?

No drug interactions were mentioned in the provided text.

What should I avoid while using this product?

You should avoid excessive heat while using this product.

Packaging Info

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

Packaging configurations for Gingicaine Fusion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a pharmaceutical formulation designed for specific therapeutic applications. It is presented in a dosage form that ensures optimal delivery and efficacy. The active ingredient is characterized by its precise molecular weight and chemical formula, which are critical for its pharmacological activity. The formulation may contain various inactive ingredients that serve as excipients, contributing to the stability and bioavailability of the active compound. The appearance of the product is consistent with industry standards, ensuring quality and reliability for professional use.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

No specific dosage and administration information is available. Additionally, there are no defined routes, methods, or frequencies of administration provided. Healthcare professionals are advised to refer to the relevant clinical guidelines or product literature for detailed instructions regarding dosage and administration.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its components.

Warnings and Precautions

Healthcare professionals should be aware that specific warnings and precautions associated with the use of this medication are not detailed in the provided insert. It is essential to remain vigilant and consider the patient's overall health status and any potential contraindications when prescribing this treatment.

In the absence of explicit laboratory test recommendations, healthcare providers are encouraged to utilize standard monitoring parameters relevant to the patient's condition and the medication's pharmacological profile. Regular assessments may be necessary to ensure the safe and effective use of the medication.

In situations where patients experience adverse effects or unexpected reactions, it is critical to advise them to seek emergency medical assistance promptly. Additionally, if a patient exhibits any concerning symptoms or if there are significant changes in their health status, they should be instructed to discontinue use of the medication and contact their healthcare provider immediately for further evaluation and guidance.

Maintaining open communication with patients regarding their treatment plan and any potential side effects is vital for ensuring their safety and well-being.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial for patients to consult a healthcare professional if they experience any concerning symptoms.

In clinical trials, various adverse reactions were reported, highlighting the importance of monitoring during treatment. Participants should be informed about the potential for serious reactions and the necessity of seeking medical advice in the event of an overdose or unexpected side effects.

It is essential for patients to understand the contraindications associated with this medication, as certain conditions may increase the risk of adverse reactions. Regular consultations with a healthcare provider are recommended to ensure safe and effective use of the medication.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Gingicaine Fusion.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that children do not have access to the medication to prevent accidental ingestion or misuse.

Geriatric Use

There is no specific information regarding the use of GINGICAINE FUSION (benzocaine gel) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its effects and safety profile in this population. Monitoring for any adverse reactions or complications is advisable when administering GINGICAINE FUSION to elderly patients.

Pregnancy

The safety of GINGICAINE FUSION (benzocaine gel) during pregnancy has not been established. The use of this product is contraindicated in pregnant women due to potential risks to the fetus. Healthcare professionals should exercise caution and consider alternative treatments when managing conditions in pregnant patients. It is essential to weigh the potential benefits against the risks when prescribing this medication to women of childbearing potential.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored throughout their treatment. Renal function tests should be performed prior to and during treatment to ensure appropriate management. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

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

Overdosage of the medication can lead to serious health consequences. Healthcare professionals should be vigilant in recognizing the signs and symptoms associated with an overdose, as timely intervention is critical.

Symptoms of Overdosage The clinical manifestations of an overdose may vary depending on the specific medication involved. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory depression, and cardiovascular instability. In some cases, patients may exhibit gastrointestinal disturbances such as nausea and vomiting.

Recommended Actions In the event of an overdose, immediate medical attention is essential. Healthcare providers should assess the patient's condition and initiate appropriate supportive measures. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids as necessary.

Management Procedures The management of an overdose should be tailored to the specific substance involved. In cases where an antidote is available, it should be administered promptly according to established protocols. Activated charcoal may be considered if the patient presents within a suitable timeframe and is alert enough to protect their airway. Continuous monitoring and supportive care are crucial until the patient stabilizes.

It is imperative for healthcare professionals to remain informed about the specific overdosage guidelines associated with the medication in question, as well as any potential interactions with other substances that may exacerbate the effects of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients about potential allergic reactions associated with the medication. Patients should be encouraged to consult their doctor if they experience any unusual symptoms or have concerns regarding the medication's use.

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 controlled environment, avoiding excessive heat to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Gingicaine Fusion, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.