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Gingicaine Gel

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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
10129-035
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Drug Overview

GingiCaine Gel is a topical gel designed for oral use, specifically indicated for providing relief from discomfort in the mouth and gums. While the specific details of its mechanism of action are not provided, it is generally used to help soothe irritation and pain in these areas.

This gel is often utilized in situations where you may experience discomfort, such as after dental procedures or due to conditions affecting the mouth. Its formulation aims to offer a calming effect, making it easier for you to manage oral discomfort.

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 use this medication safely and effectively, you should refer to the images labeled "Gingicaine-Dosage and Admin-001.jpg" and "Gingicaine-Dosage and Admin-002.jpg." These images contain important information about how to prepare and administer the medication, including the specific route (how the medication is given), method (the technique used), and frequency (how often you should take or apply it).

Make sure to follow the instructions in these images closely to ensure you are using the medication correctly. If you have any questions or need further clarification, don’t hesitate to ask your healthcare provider for assistance.

What to Avoid

It seems that the information regarding what to avoid while using this medication is not specified in the provided text. Therefore, I recommend consulting your healthcare provider or the medication's official guidelines for detailed information on contraindications, controlled substance classification, risks of abuse or misuse, dependence concerns, and specific instructions on when not to take or use the medication. Your safety and well-being are important, so please ensure you have all the necessary information before proceeding.

Side Effects

It's important to be aware of potential side effects when taking medication. You should consult your doctor promptly if you experience any unusual symptoms or reactions. While specific side effects were not detailed, staying informed and communicating with your healthcare provider can help ensure your safety and well-being. Always prioritize your health by discussing any concerns with your doctor.

Warnings and Precautions

It's important to be aware of certain warnings and precautions when using this medication. While specific emergency help instructions and lab tests are not provided, you should always be cautious and monitor your health closely. If you experience any unusual symptoms or side effects, it's essential to stop taking the medication and contact your doctor for guidance.

Make sure to discuss your medical history and any other medications you are taking with your healthcare provider to avoid potential interactions. Staying informed and proactive about your health can help ensure safe and effective use of this medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific details about overdose symptoms or treatment in the available information, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware 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.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

Currently, there is no specific information available about the use of GINGICAINE GEL for nursing mothers or during lactation (the period of breastfeeding). This means that it’s unclear how this medication may affect you or your breast milk.

If you are breastfeeding or planning to breastfeed, it’s always best to consult with your healthcare provider before using any new medication. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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 compromise its effectiveness. 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 how they fit into its use and safety. Proper disposal of any used materials is also crucial to prevent any potential hazards. Always prioritize following these guidelines for optimal results.

Additional Information

No further information is available.

FAQ

What is GingiCaine Gel?

GingiCaine Gel is a topical medication indicated for specific uses, although detailed indications are not provided in the text.

How should I administer GingiCaine Gel?

Dosage and administration details are available in referenced images, but specific instructions are not provided in the text.

Are there any contraindications for GingiCaine Gel?

The text does not specify any contraindications for GingiCaine Gel.

What precautions should I take when using GingiCaine Gel?

General precautions are referenced in an image, but specific details are not provided in the text.

Is GingiCaine Gel safe for children?

You should keep GingiCaine Gel out of reach of children, but specific safety information for pediatric use is not provided.

Can I use GingiCaine Gel during pregnancy?

The text does not provide specific information regarding the use of GingiCaine Gel during pregnancy.

What should I do in case of an emergency while using GingiCaine Gel?

The text does not mention specific emergency instructions related to GingiCaine Gel.

What should I do if I experience side effects?

You should consult a doctor promptly if you experience any side effects, although specific side effects are not detailed in the text.

Are there any known drug interactions with GingiCaine Gel?

The text does not mention any drug interactions associated with GingiCaine Gel.

What should I avoid while using GingiCaine Gel?

You should avoid excessive heat while using GingiCaine Gel.

Packaging Info

Below are the non-prescription pack sizes of Gingicaine Gel (gingicaine gel banana flavor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GingiCaine Gel Banana is a topical formulation presented as a gel. The active ingredient in this product is benzocaine, with a strength of 20%. The gel is characterized by its yellow color and banana flavor.

Inactive ingredients include carbomer, glycerin, methylparaben, propylparaben, and purified water. GingiCaine Gel Banana is packaged in jars for distribution.

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 should refer to the images titled "Gingicaine-Dosage and Admin-001.jpg" and "Gingicaine-Dosage and Admin-002.jpg" for comprehensive information regarding the dosage and administration of the medication. These images contain essential details on the appropriate dosing ranges, administration routes, methods, and frequency of administration. It is crucial to consult these resources to ensure accurate and effective use of the medication in clinical practice.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment when considering its use in patients with potential risk factors or underlying conditions.

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 and response to therapy.

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 the 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 promptly if they experience any concerning symptoms or reactions 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. This proactive approach ensures timely intervention and management of any potential complications that may arise.

Healthcare professionals should remain vigilant and provide guidance to patients regarding the importance of recognizing and addressing adverse reactions as part of the overall treatment plan.

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 Gel (gingicaine gel banana flavor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when considering its use in this demographic.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the context of the patient's clinical situation. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the use of GINGICAINE GEL in lactating mothers or its effects on breastfed infants. Healthcare professionals should exercise caution when prescribing this medication to nursing mothers, as the absence of data does not rule out potential risks. It is advisable to consider the benefits of treatment against any potential risks to the nursing infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 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 care. 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, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to provide comprehensive care tailored to the patient's needs, including potential interventions based on the clinical presentation.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and individualized patient 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 use of the compound in these contexts.

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 or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Gingicaine Gel, 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, 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.