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Benzocaine

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This product has been discontinued

Active ingredient
Benzocaine 200 mg
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Oral
  • Periodontal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1993
Label revision date
December 8, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg
Other brand names
Dosage form
Gel
Routes
  • Dental
  • Oral
  • Periodontal
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 1993
Label revision date
December 8, 2021
Manufacturer
Gingi-Pak a Division of the Belport
Registration number
part356
NDC root
10129-037
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

GingiCaine Gel is a flavored gel designed for oral use, specifically available in a Cotton Candy flavor. While the bullet list does not provide specific details about its uses or how it works, it is typically used to help manage discomfort in the mouth. If you have any questions about how GingiCaine Gel may be beneficial for you, it's a good idea to consult with a healthcare professional for more information.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no details regarding any potential teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information, it's best to consult with a healthcare professional.

Dosage and Administration

To ensure you use your medication correctly, please refer to the images provided for detailed dosage and administration instructions. These images will guide you on how to prepare and take your medication safely.

It's important to follow the specific route (how the medication is given), method (the technique used), and frequency (how often you should take it) as outlined in the images. This will help you achieve the best results from your treatment. If you have any questions about the instructions, don't hesitate to ask your healthcare provider for clarification.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with it. This means that, based on the information available, there are no particular situations or conditions that would prevent you from taking this medication, nor are there any specific instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential side effects when taking medication. Some individuals may experience serious reactions, including severe allergic reactions (anaphylaxis), which can be life-threatening. If you notice symptoms like difficulty breathing, swelling of the face or throat, or a rapid heartbeat, seek medical attention immediately.

Common side effects may include mild symptoms such as nausea, headache, or dizziness. While these are generally not severe, it's always a good idea to consult your doctor if you have any concerns or if these symptoms persist. Remember, your healthcare provider can help you manage any side effects you may experience.

Warnings and Precautions

It's important to be aware of certain warnings and precautions when using this medication. If you experience any unusual symptoms or side effects, it's crucial to stop taking the medication and contact your doctor immediately. Always discuss your medical history and any other medications you are taking with your healthcare provider to avoid potential interactions.

While there are no specific laboratory tests required for monitoring, staying vigilant about your health is essential. If you have any concerns or notice changes in your condition, don't hesitate to reach out to your healthcare professional for guidance. Your safety and well-being should always come first.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical attention immediately.

Signs of an overdose can vary, but common symptoms may include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for guidance. Your safety is the top priority, so it's always better to err on the side of caution.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding and considering using GingiCaine Gel, it’s important to consult your doctor first. This is because there is a possibility that the gel can be passed into your breast milk. The effects of this medication on nursing infants have not been thoroughly studied, so exercising caution is recommended. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health needs. Always keep them informed about all the medications and tests you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it in a cool, dry place. Avoid exposing it to excessive heat, as this can compromise its quality. When handling the product, make sure to follow any specific instructions provided to maintain its integrity and safety.

If you have any components that come with the product, be sure to understand their role in its use and safety. Proper disposal of any used materials is also crucial to prevent contamination or other safety issues. Always prioritize these guidelines to ensure the best results.

Additional Information

You can take this medication through different methods, including dental, oral, and periodontal (related to the gums). There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market.

FAQ

What is GingiCaine Gel?

GingiCaine Gel is a dental gel presented in a Cotton Candy flavor.

What are the indications and usage for GingiCaine Gel?

No specific indications or usage details are provided in the text.

How should I administer GingiCaine Gel?

Refer to the images for detailed dosage and administration instructions.

Are there any contraindications for GingiCaine Gel?

No specific contraindications are listed in the provided text.

What precautions should I take when using GingiCaine Gel?

General precautions can be found in the referenced image.

Can I use GingiCaine Gel while pregnant?

No specific information regarding pregnancy use is provided; consult your doctor.

Is it safe to use GingiCaine Gel while nursing?

Nursing mothers should consult a doctor before using GingiCaine Gel, as it may be excreted in breast milk.

What should I do in case of an emergency?

No specific emergency instructions are mentioned in the text.

How should I store GingiCaine Gel?

Avoid excessive heat and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Gingicaine Gel, Cotton Candy Flavor. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel, Cotton Candy Flavor.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GingiCaine Gel is presented in a jar labeled with a cotton candy theme. The formulation is designed for topical application, providing a unique aesthetic appeal while serving its intended purpose in dental care.

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

Healthcare professionals are advised to refer to the provided images for comprehensive dosage and administration instructions specific to the medication.

The route, method, and frequency of administration are detailed in the images, which should be consulted to ensure accurate dosing. It is essential to adhere to the guidelines presented in these images to optimize therapeutic outcomes and maintain patient safety.

Contraindications

There are no specific contraindications identified for the use of this product. No controlled substance classification, abuse or misuse risks, dependence concerns, or "do not take" instructions have been noted in the available data.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Warnings It is imperative to consult the accompanying image reference for detailed warnings related to the use of this medication. These warnings are critical for ensuring patient safety and should be reviewed thoroughly.

General Precautions Healthcare providers should exercise caution when prescribing this medication. The accompanying image reference outlines specific precautions that must be considered to mitigate potential risks associated with its use. It is essential to evaluate each patient's individual health status and history before initiating treatment.

Laboratory Tests Currently, there are no specific laboratory tests recommended for monitoring the use of this medication. However, healthcare professionals should remain vigilant and consider appropriate clinical assessments based on the patient's condition.

In the event of any adverse reactions or concerns, healthcare professionals are advised to take appropriate action based on clinical judgment and the specific circumstances of the patient.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. While specific adverse reactions have not been detailed in the provided information, it is essential for patients to consult a doctor regarding any concerns or symptoms that may arise during treatment.

In clinical practice, monitoring for adverse reactions is crucial, and patients are encouraged to report any unusual or severe symptoms to their healthcare provider promptly. This proactive approach ensures that any serious reactions can be addressed swiftly and appropriately.

Additionally, patients should be informed about the importance of discussing their medical history and any concurrent medications with their healthcare provider to minimize the risk of adverse reactions. Regular follow-up appointments may be necessary to assess the patient's response to the medication and to manage any potential side effects effectively.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. 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 Gel, Cotton Candy Flavor. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel, Cotton Candy Flavor.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

Nursing mothers should consult a doctor before using GingiCaine Gel. There is a potential for excretion of the drug in breast milk. The effects on a nursing infant are not well studied; therefore, caution is advised when administering this product to lactating mothers.

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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures In the absence of detailed guidance, standard protocols for managing drug overdosage should be followed. This may include gastric decontamination, administration of activated charcoal if appropriate, and supportive care tailored to the patient's needs. Consultation with a poison control center or a medical toxicologist is recommended for further guidance in managing suspected overdosage cases.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to the ongoing assessment of the product's safety profile.

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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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 exposure to excessive heat to maintain its integrity and efficacy. Proper handling procedures should be followed to ensure optimal storage conditions are met.

Additional Clinical Information

The route of administration for the product includes dental, oral, and periodontal methods. 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 Gingicaine Gel, Cotton Candy Flavor, 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 Gel, Cotton Candy Flavor, 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.