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Gingicaine Gel, Pina Colada

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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 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
10129-033
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 topical gel that comes in a Pina Colada flavor. It is designed for use in specific dental applications, although the exact indications and uses are not detailed in the provided information. For more information about how GingiCaine Gel can help you, images are available to guide you further.

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no details regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects (which do not cause such defects). 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 safely and effectively, it's important to follow the specific dosage and administration instructions provided. You can find detailed guidance in the images labeled "Gingicaine-Dosage and Admin-001.jpg" and "Gingicaine-Dosage and Admin-002.jpg."

These images will outline how much of the medication you should take, how to take it (for example, whether it should be taken orally or applied topically), and how often you should use it. Make sure to refer to these images closely to understand the correct steps for your treatment. If you have any questions or uncertainties, don’t hesitate to reach out to your healthcare provider for clarification.

What to Avoid

While there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence mentioned, it's always important to use medications responsibly. If you have any questions or uncertainties about taking a particular medication, please consult your healthcare provider for personalized advice. They can help ensure that you use the medication safely and effectively.

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 are not detailed here, being vigilant about your health and communicating with your healthcare provider can help ensure your safety.

Always follow your doctor's advice and report any concerns you may have regarding your treatment. Your well-being is the priority, and staying informed is a key part of managing your health.

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 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 your medication, you should seek medical help immediately.

Signs of an overdose can vary, but they may include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, or if you are unsure about your situation, 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 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 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 regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding and considering using GingiCaine Gel, it’s important to talk to your doctor first. This is because there is a possibility that the gel could be passed into your breast milk, and the safety of this product for both you and your baby has not been fully established. Always prioritize your health and your infant's well-being by seeking professional advice before using any new medication.

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 for patients with 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 and what steps to take for your safety.

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, so don't hesitate to ask questions or express any concerns you may have.

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 may 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. Always dispose of any materials according to local regulations to ensure safe and responsible disposal.

Additional Information

You can take this medication through different methods, including dental, oral, and periodontal (related to the gums) routes. Unfortunately, there is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about how to use this medication, it's best to consult your healthcare provider.

FAQ

What is GingiCaine Gel?

GingiCaine Gel is a dental gel with a Pina Colada flavor.

What are the indications and uses for GingiCaine Gel?

Specific indications and usage details are not provided; please refer to the images for more information.

Are there any teratogenic effects associated with GingiCaine Gel?

No teratogenic effects are mentioned in the text.

What should I do if I am nursing?

If you are nursing, consult a doctor before using GingiCaine Gel, as it may be excreted in breast milk.

How should I administer GingiCaine Gel?

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

Are there any warnings or precautions I should be aware of?

Warnings and general precautions are referenced in images; please review them for important safety information.

Is GingiCaine Gel safe for children?

Keep GingiCaine Gel out of reach of children.

What should I do in case of an emergency?

Specific emergency medical help instructions are not mentioned; consult a healthcare professional for guidance.

Are there any contraindications for using GingiCaine Gel?

No specific contraindications are listed in the provided text.

Can I use GingiCaine Gel if I have liver or kidney problems?

No specific information regarding use in patients with liver or kidney problems is provided.

Packaging Info

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

Packaging configurations for Gingicaine Gel, Pina Colada.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GingiCaine Gel, Pina Colada is a topical anesthetic formulation. It contains 20% w/w Benzocaine as the active ingredient. The gel is composed of several inactive ingredients, including Carbomer, Glycerin, Methylparaben, Propylparaben, Purified Water, and Sodium Hydroxide. GingiCaine Gel is characterized by its clear, colorless to pale yellow appearance and possesses a distinctive odor.

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 pertaining to the medication. The images contain detailed information regarding the specific dosage amounts, routes of administration, methods, and recommended frequencies. It is essential to consult these visual aids to ensure accurate and effective use of the medication in clinical practice.

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.

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 assess the patient's clinical response and any emerging side effects during the course of treatment.

Emergency Medical Help While no specific emergency instructions are provided, healthcare professionals should be prepared to respond to any adverse reactions that may arise during treatment. Immediate medical intervention may be necessary in such cases.

Discontinuation of Treatment Although no specific instructions are provided regarding when to stop taking the medication, healthcare professionals should advise patients to report any concerning symptoms or side effects promptly. A thorough evaluation may be warranted to determine the appropriateness of continuing therapy.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this medication. It is crucial for patients to consult a doctor promptly if they experience any concerning symptoms or reactions.

In clinical trials, various adverse reactions were reported, highlighting the importance of monitoring for these effects. Participants should be informed of the necessity to report any unusual or severe symptoms to their healthcare provider immediately.

Additionally, precautions should be taken to minimize the risk of adverse reactions. Patients are encouraged 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 for this product. 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, Pina Colada (gingicaine gel, pina colada flavor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gingicaine Gel, Pina Colada.
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 specific dosing recommendations for children are not provided. Caution is advised when administering this medication to ensure it is not accessible to young children.

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 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

Nursing mothers should consult a doctor before using GingiCaine Gel. There is a potential for excretion of the drug in breast milk. The safety of GingiCaine Gel for lactating mothers and their breastfed infants has not been established.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 consider general principles of management for 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 prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures In cases of suspected overdosage, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on management strategies. Supportive measures, including the maintenance of airway, breathing, and circulation, should be implemented as necessary.

Healthcare professionals are encouraged to report any cases of overdosage 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 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 the 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 children.

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 adhered to, ensuring that the product is kept within the recommended temperature range to prevent degradation. Special handling precautions should be taken to protect the product from extreme temperatures and environmental factors that may compromise its quality.

Additional Clinical Information

The route of administration for the product includes dental, oral, and periodontal applications. 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, Pina Colada, 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, Pina Colada, 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.