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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 2014
Label revision date
January 11, 2018
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 2014
Label revision date
January 11, 2018
Manufacturer
Gingi-Pak a Division of the Belport
Registration number
part356
NDC root
10129-070
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 gel product designed for oral use, specifically formulated to provide relief in various dental situations. While the specific indications and uses are not detailed, it is generally intended to help soothe discomfort in the mouth and gums.

This product comes in a variety pack, allowing for different applications as needed. If you're experiencing oral discomfort, Gingicaine may be a supportive option to consider for temporary relief.

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

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 (the way the medication is delivered), method (how it is applied or taken), and frequency (how often you should take it) as outlined in the images. This will help you get 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

It’s important to be aware of certain situations where you should not use this medication. If you have specific allergies or conditions, such as those listed in the contraindications, you should avoid taking it. Always check with your healthcare provider if you have any concerns about your allergies or health conditions before starting this medication.

Additionally, if you experience any allergic reactions, such as severe skin rashes or difficulty breathing, you should stop using the medication immediately and seek medical attention. Your safety is a priority, so make sure to discuss any potential risks with your doctor.

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 stop-use guidelines are not provided, you should always be cautious and monitor how you feel while taking it. If you experience any unusual symptoms or have concerns, it's best to reach out to your healthcare provider for guidance.

There are no specific laboratory tests required for monitoring while using this medication, but staying informed about your health is crucial. Always consult your doctor if you have any questions or if something doesn’t feel right. Your well-being is the top priority, so don’t hesitate to seek help when needed.

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 help 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 symptoms, do not hesitate to contact a healthcare professional or call emergency services for assistance. 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 be aware that there is no specific information available regarding 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 consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since the potential impact on milk production or your baby is not clearly defined, it’s advisable to consult with your healthcare provider for personalized guidance. They can help you weigh the benefits and risks based on your individual situation.

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 about how to manage medications in your home, don't hesitate to ask 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have kidney issues, it's important to consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help ensure your treatment is safe and effective based on your individual 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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no known 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 to ensure a safe and effective experience.

Additional Information

No further information is available.

FAQ

What is Gingicaine?

Gingicaine is a gel variety pack used for unspecified indications and uses.

How should I administer Gingicaine?

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

Are there any contraindications for Gingicaine?

Yes, there are contraindications listed as contraindications001 and contraindications002.

What should I do if I have an allergy?

You should not use Gingicaine if you have any of the allergy alerts mentioned, such as Allergy Alert001 and Allergy Alert002.

What precautions should I take with Gingicaine?

General precautions are available in the referenced image, and you should consult a doctor promptly if needed.

Is there any information about using Gingicaine during pregnancy or while nursing?

No specific information regarding use during pregnancy or nursing mothers is provided.

How should I store Gingicaine?

Keep Gingicaine out of reach of children and avoid excessive heat.

Packaging Info

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

Packaging configurations for Gingicaine Gel Variety Pak.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Gingicaine Gel Variety Pak Labels are designed for use with the GingiCaine Gel product line. The effective time for these labels is noted as January 11, 2018. The observation media is categorized as a Variety Pak, and the media type is specified as image/jpeg. The reference value for the labels is documented as GingiCaine Gel Variety Pak.jpg.

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 within the referenced images, which should be consulted to ensure accurate and effective use of the medication. It is essential to adhere to the guidelines presented in these images to optimize patient outcomes and maintain safety standards.

Contraindications

Use is contraindicated in patients with Contraindications001 and Contraindications002.

Additionally, the product should not be administered to individuals with a known allergy to Allergy Alert001 or Allergy Alert002 due to the potential for severe allergic reactions.

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 provided 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. Refer to the accompanying image reference for comprehensive precautions that must be considered to mitigate potential risks associated with its use.

Laboratory Tests Currently, there are no specific laboratory tests recommended for monitoring patients on this medication. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment as part of standard care.

In the absence of specific emergency medical help instructions or directives to stop taking the medication, healthcare providers are encouraged to maintain open communication with patients regarding any adverse effects or concerns that may arise during treatment.

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 crucial 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 essential, 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 for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

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

Packaging configurations for Gingicaine Gel Variety Pak.
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

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 importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants have not been established. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 following excessive administration of the product.

Management Procedures In the absence of specific antidotes or treatment protocols, the management of overdosage should focus on supportive care and symptomatic relief. Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance tailored to the specific circumstances of the case.

It is imperative that healthcare providers document any instances of overdosage and report them to the appropriate regulatory authorities to contribute to the ongoing assessment of the product's safety profile.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 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 Variety Pak, 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 Variety Pak, 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.