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Gingicaine Gel, Chocolate Mint

Last content change checked dailysee data sync status

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 9, 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 9, 2021
Manufacturer
Gingi-Pak a Division of the Belport
Registration number
part356
NDC root
10129-034
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 is a mint chocolate-flavored product designed for use in specific medical situations. While the exact details of its indications and uses are not provided, it is important to know that it serves a particular purpose in healthcare. If you have questions about how Gingicaine may be beneficial for you, consider discussing it with your healthcare provider for more personalized 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

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What to Avoid

It's important to be aware of certain considerations when using this medication. While specific contraindications (conditions that would make the use of the drug inadvisable) and "do not use" instructions are not provided, you should always consult with your healthcare provider about your medical history and any other medications you are taking. This will help ensure that the medication is safe and appropriate for you.

Additionally, while there are no details regarding the risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance), it's crucial to use this medication only as directed by your healthcare professional. If you have any concerns or questions about your treatment, don't hesitate to reach out to your doctor for guidance.

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 warnings and precautions are not detailed here, 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. 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 current medications with your healthcare provider to ensure this treatment is safe for you.

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 stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor promptly about any medications you may be taking. This is crucial to ensure your safety and the health of your baby. Be aware of any allergies you may have, as well as any contraindications (situations where a drug should not be used) that could affect your treatment options.

Additionally, pay attention to any warnings associated with your medications. These warnings are designed to help you avoid potential risks during pregnancy. Always discuss your concerns and any specific health conditions with your healthcare provider to make informed decisions about your care.

Lactation Use

If you are breastfeeding and considering the use of GingiCaine Gel, it’s important to consult your doctor as soon as possible. This is because there is a possibility that the ingredients in this gel can be passed into your breast milk. To ensure the safety of both you and your nursing infant, exercising caution is advised when using this product. Always prioritize open communication with your healthcare provider to make informed decisions about your care while breastfeeding.

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 available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided text. Therefore, if you have kidney issues, it's important to consult your healthcare provider for personalized advice and recommendations regarding any medications you may be taking. They can provide guidance tailored to your specific health needs.

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 need to conduct regular tests 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, tailored specifically to your health needs.

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

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 a sterile environment (a clean area free from germs) and to prevent contamination.

If you have any components that come with the product, be sure to understand their role in its use and safety. Always dispose of any materials according to local regulations to ensure safe and responsible handling.

Additional Information

No further information is available.

FAQ

What is Gingicaine?

Gingicaine is a drug with a mint chocolate flavor.

What are the indications and uses for Gingicaine?

Specific indications and usage details for Gingicaine are not provided.

Are there any teratogenic effects associated with Gingicaine?

No teratogenic effects are mentioned for Gingicaine.

What should I know about dosage and administration of Gingicaine?

For dosage and administration details, please refer to the provided images.

Are there any contraindications for using Gingicaine?

Specific contraindications are not listed for Gingicaine.

What precautions should I take when using Gingicaine?

General precautions are available in the provided image references.

What should nursing mothers know about Gingicaine?

Nursing mothers should consult a doctor promptly regarding the use of Gingicaine, as there is a potential for excretion in breast milk.

How should I store Gingicaine?

Gingicaine should be kept out of reach of children and stored away from excessive heat.

What should I do if I have concerns about using Gingicaine?

You should consult a doctor promptly if you have any concerns regarding the use of Gingicaine.

Packaging Info

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

Packaging configurations for Gingicaine Gel, Chocolate Mint.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is presented in a jar labeled with a mint chocolate flavor.

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

The recommended dosage of the medication is determined by the specific condition being treated, the patient's age, and their overall health status. Healthcare professionals should refer to the detailed prescribing information for precise dosing ranges and adjustments.

For administration, the medication should be administered via the appropriate route as indicated in the prescribing information. It is essential to follow the recommended preparation techniques to ensure the efficacy and safety of the treatment.

Dosing intervals may vary based on the patient's response and the severity of the condition. Regular monitoring of the patient's progress is advised to determine if adjustments to the dosage or frequency are necessary.

Healthcare professionals are encouraged to consult the prescribing information for comprehensive guidelines on dosage adjustments, potential contraindications, and any specific considerations related to patient populations.

Contraindications

There are no specific contraindications, "do not use" instructions, or details regarding controlled substance classification, abuse or misuse risks, or dependence concerns provided in the available data. Therefore, healthcare professionals should exercise clinical judgment when considering the use of this product in individual patients.

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 adverse reactions or complications, healthcare professionals are advised to follow standard protocols for patient management. Regular follow-up and patient education regarding the signs and symptoms that warrant immediate medical attention are crucial for ensuring safe and effective treatment.

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 doctor promptly if they experience any concerning symptoms.

In clinical trials, various adverse reactions were reported, highlighting the importance of monitoring for these effects. Participants should be informed of the potential risks and encouraged to report any unusual symptoms to their healthcare provider.

Precautions should be taken to minimize the risk of adverse reactions. Patients are advised to discuss their medical history and any concurrent medications with their healthcare provider to ensure safe 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 Gel, Chocolate Mint (gingicaine gel, chocolate mint flavor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel, Chocolate Mint.
Details

Pediatric Use

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

Geriatric Use

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional promptly if they are considering the use of this medication. It is important to evaluate the potential risks and benefits, as well as any contraindications related to allergies.

Healthcare providers should be aware of the warnings associated with this medication, as they may have implications for fetal outcomes. The safety of this medication during pregnancy has not been fully established, and caution is advised when prescribing to women of childbearing potential.

In summary, careful consideration and consultation with a healthcare provider are essential for pregnant patients or those planning to become pregnant.

Lactation

Nursing mothers should consult a doctor promptly regarding the use of GingiCaine Gel. There is a potential for excretion in breast milk; therefore, caution is advised when administering this product to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to 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 is no information available regarding 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.

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 pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, standard overdosage management practices should be followed. This may include gastric decontamination, such as activated charcoal administration, if appropriate and within the timeframe of ingestion. Continuous monitoring and supportive care are critical until the patient stabilizes.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to enhance the understanding of the drug's safety profile and to contribute to the ongoing evaluation of its risk management strategies.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 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 Gel, Chocolate Mint, 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, Chocolate Mint, 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.