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Nene Dente

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This product has been discontinued

Active ingredient
Benzocaine 2.1 mg/30 mL
Other brand names
Dosage form
Liquid
Route
Topical
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 23, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 2.1 mg/30 mL
Other brand names
Dosage form
Liquid
Route
Topical
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 23, 2015
Manufacturer
Menper Distributors, Inc
Registration number
part356
NDC root
53145-335
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

Nene Dente is a medication designed to provide temporary relief from sore gums caused by teething in infants and children aged 4 months and older. If your little one is experiencing discomfort during this developmental stage, Nene Dente may help soothe their gums and ease their pain.

Uses

If your child is experiencing sore gums from teething, this medication can provide temporary relief for infants and children who are at least 4 months old. Teething can be uncomfortable for little ones, and this product is designed to help ease that discomfort, making it easier for them during this developmental stage.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe for use in the recommended age group.

Dosage and Administration

Before using the medication, make sure to wash your hands thoroughly to keep everything clean. Next, remove the safety seal from the bottle. You can then use your fingertip or a cotton swab to apply 2 to 4 drops of the medication directly to the affected area. You should do this no more than four times a day, unless your doctor has given you different instructions.

If you are caring for an infant under 4 months old, it's important to note that there is no recommended dosage or treatment for them unless specifically advised and supervised by a dentist or physician. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other "caine" anesthetics. Additionally, do not use this medication for more than 7 days unless your doctor specifically instructs you to do so. It's important to follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to be aware of potential side effects when using this medication. You should stop using it and consult your doctor if you experience sore mouth symptoms that do not improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens. Additionally, seek medical attention if you develop swelling, a rash, or a fever.

Always remember to follow the recommended dosage and keep this and all medications out of the reach of children. Symptoms like fever and nasal congestion are not typical signs of teething and may indicate an infection, so it's best to consult your physician if these symptoms persist.

Warnings and Precautions

It's important to use this medication safely. Always follow the recommended dosage and keep it out of reach of children. If you notice fever and nasal congestion, these may not be signs of teething and could indicate an infection; consult your doctor if these symptoms persist.

You should not use this medication for more than 7 days unless your doctor advises otherwise. Additionally, avoid using it if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

If your sore mouth symptoms do not improve after 7 days, or if you experience worsening irritation, pain, or redness, stop using the medication and contact your doctor. Also, seek medical advice if you develop swelling, a rash, or a fever.

Overdose

It's important to follow the recommended dosage of your medication carefully. Taking more than the advised amount can lead to an overdose, which can be serious. Signs of an overdose may include unusual symptoms that you should be aware of.

If you suspect that you or someone else has taken too much of the medication, seek immediate medical help. It's crucial to act quickly, as timely intervention can make a significant difference. Always remember, when in doubt, it's better to consult a healthcare professional.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation.

In the event of accidental ingestion, seek medical assistance immediately or contact a Poison Control Center. Your health and the health of your baby are paramount, so don’t hesitate to reach out for help if needed.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

You can use this medication to help temporarily relieve sore gums in infants and children who are 4 months old and older, especially during teething. However, if your child is under 4 months of age, it’s important to consult with a dentist or physician before giving any treatment, as there are no recommended dosages for this age group. Always prioritize professional guidance to ensure your child's safety and well-being.

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 before starting the medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be aware of potential interactions when taking medications. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other "caine" anesthetics, you should avoid using this medication. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

While there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best quality and safety of your product, store it in a cool, dry place at a temperature between 15-30°C (59-86°F). Before using, check that the printed plastic bottle wrap is intact; do not use the product if it is broken, torn, or missing, as this could compromise its safety.

It's also a good idea to keep the outer carton, as it contains important directions and warnings that you may need to refer to later. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Nene Dente used for?

Nene Dente is used for the temporary relief of sore gums due to teething in infants and children 4 months of age and older.

How should I apply Nene Dente?

Wash your hands, remove the safety seal, and use your fingertip or a cotton swab to apply 2-4 drops to the affected area, not more than four times daily or as directed by a physician.

What should I do if symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, stop use and see a doctor.

Are there any contraindications for using Nene Dente?

Do not use Nene Dente if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

Can I use Nene Dente for infants under 4 months?

There is no recommended dosage or treatment for infants under 4 months of age except under the advice and supervision of a dentist or physician.

What precautions should I take when using Nene Dente?

Do not exceed the recommended dosage, keep it out of reach of children, and consult a physician if fever or nasal congestion develops, as these are not symptoms of teething.

What should I do in case of accidental ingestion?

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Is it safe to use Nene Dente while pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store Nene Dente?

Store Nene Dente between 15-30°C (59-86°F) and do not use if the printed plastic bottle wrap is broken, torn, or missing prior to opening.

Packaging Info

Below are the non-prescription pack sizes of Nene Dente (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nene Dente.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Nene Dente is presented in an image/jpeg media format. The reference file for this product is labeled as nenedent.jpg.

Uses and Indications

This drug is indicated for the temporary relief of sore gums due to teething in infants and children aged 4 months and older.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients to wash their hands thoroughly before applying the medication. The imprinted safety seal on the bottle must be removed prior to use.

For application, patients should use a fingertip or a cotton swab to apply 2 to 4 drops of the medication directly to the affected area. This application may be performed up to four times daily, or as directed by a physician.

It is important to note that for infants under 4 months of age, there is no recommended dosage or treatment unless advised and supervised by a dentist or physician.

Contraindications

Use is contraindicated in patients with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, due to the risk of severe allergic reactions. Additionally, the product should not be used for more than 7 days unless directed by a physician to avoid potential complications associated with prolonged use.

Warnings and Precautions

Patients should not exceed the recommended dosage of this medication. It is imperative to keep this and all medications out of the reach of children to prevent accidental ingestion. Healthcare professionals should be aware that fever and nasal congestion are not typical symptoms of teething; rather, they may indicate an underlying infection. If these symptoms persist, a consultation with a physician is advised.

In terms of general precautions, this medication should not be used for more than 7 days unless specifically directed by a physician. Additionally, individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid using this product.

Patients are instructed to discontinue use and contact their healthcare provider if sore mouth symptoms do not improve within 7 days. Furthermore, if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, immediate medical advice should be sought.

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 to adhere to the recommended dosage to minimize risks.

In clinical practice, patients are advised to discontinue use and consult a physician if sore mouth symptoms do not improve within 7 days. Additionally, if any irritation, pain, or redness persists or worsens, medical advice should be sought. Patients should also be vigilant for the development of swelling, rash, or fever, as these may indicate a more serious condition requiring immediate attention.

It is important to note that fever and nasal congestion are not typical symptoms of teething and may suggest the presence of an infection. In such cases, patients should consult their physician promptly. Furthermore, this medication should be kept out of the reach of children to prevent accidental ingestion or misuse.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of this medication due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Nene Dente (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nene Dente.
Details

Pediatric Use

Pediatric patients 4 months of age and older may use this product for the temporary relief of sore gums due to teething. For infants under 4 months of age, there is no recommended dosage or treatment, and use should only occur under the advice and supervision of a dentist or physician.

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 and those who are breastfeeding should consult a healthcare professional prior to use. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the recommended dosage may lead to serious health complications.

Potential Symptoms of Overdosage Symptoms associated with overdosage can vary depending on the specific substance involved. Healthcare professionals should be vigilant for signs of toxicity, which may include but are not limited to neurological disturbances, gastrointestinal symptoms, and cardiovascular irregularities.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and initiate appropriate management protocols. This may involve supportive care, monitoring vital signs, and administering specific antidotes if available and indicated.

Management Procedures Management of overdosage should be tailored to the individual patient and the substance involved. Healthcare professionals are advised to consult relevant toxicology resources and follow established clinical guidelines to ensure optimal patient outcomes. Continuous monitoring and supportive care are essential components of effective management in cases of overdosage.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use. The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within 7 days, it is recommended to discontinue use and seek medical advice. In cases where irritation, pain, or redness persists or worsens, discontinuation of use and consultation with a doctor is advised. Additionally, if any swelling, rash, or fever develops, it is important to stop use and contact a healthcare professional.

No relevant information regarding carcinogenicity, mutagenicity, or animal pharmacology and toxicology has been extracted.

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. It is important to inform patients that the product should not be used for more than 7 days unless directed by a physician, as prolonged use may lead to complications.

Patients should be cautioned against using the medication if they have a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, to avoid potential allergic reactions.

Healthcare providers should instruct patients to discontinue use and seek medical attention if symptoms of a sore mouth do not improve within 7 days. Additionally, patients should be advised to stop using the product and consult a doctor if they experience persistent or worsening irritation, pain, or redness. They should also be informed to seek medical advice if they develop swelling, rash, or fever while using the medication.

Storage and Handling

This product is supplied in a plastic bottle, and it is essential to store it at a temperature range of 15-30°C (59-86°F). Healthcare professionals should ensure that the printed plastic bottle wrap is intact; do not use the product if the wrap is broken, torn, or missing prior to opening. It is advisable to retain the outer carton, as it contains important directions and warnings related to the product's use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Nene Dente, 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 Nene Dente, 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.

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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.