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Baby Teething Oral Pain Reliever

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This product has been discontinued

Active ingredient
Benzocaine 7.5 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
May 1, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 7.5 g/100 g
Other brand names
Dosage form
Gel
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 2010
Label revision date
May 1, 2010
Manufacturer
Budpak Inc.
Registration number
part356
NDC root
27293-013
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

Teething can be a challenging time for both infants and their parents. This medication is designed to temporarily relieve sore gums caused by teething in infants and children aged 4 months and older. It aims to provide comfort during this uncomfortable phase, helping your little one feel better as their teeth begin to emerge.

Uses

If your little one is experiencing sore gums from teething, this medication can help provide temporary relief. It's suitable for infants and children who are at least 4 months old. Teething can be uncomfortable for babies, but with this treatment, you can help ease their discomfort and make the process a bit more bearable for both of you.

Dosage and Administration

Before using Budpack Baby Teething Gel Medicine, make sure to wash your hands thoroughly. This helps prevent any germs from getting into the medicine or your baby's mouth. Next, take a small amount of the gel, about the size of a pea, using your fingertip or a cotton applicator.

You can apply the gel to the affected area in your baby's mouth up to four times a day, or as your dentist or doctor advises. If your baby is under 4 months old, it's important to consult with a doctor before using this product. This ensures that you are using it safely and effectively for your little one.

What to Avoid

It's important to use this medication responsibly. You should not use it for more than 7 days unless your doctor specifically advises you to do so. Additionally, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. This will help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider.

Side Effects

If your baby has a history of allergies to local anesthetics like procaine or butacaine, it's important not to use this product. You should also stop using it and consult a dentist or physician if your baby experiences any of the following: sore mouth symptoms that don’t improve within 7 days, ongoing irritation, pain, or redness, or if they develop swelling, a rash, or a fever. These could be signs of a more serious issue that needs medical attention.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If your baby has a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), do not use this product.

If your baby experiences sore mouth symptoms that do not improve within 7 days, or if there is ongoing irritation, pain, or redness, you should stop using the product and consult a dentist or physician. Additionally, seek medical attention if your baby develops swelling, a rash, or a fever.

In the event of an overdose or an allergic reaction, it is crucial to get emergency medical help immediately by contacting a Poison Control Center.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

When considering the use of Baby Teething Oral Pain Reliever, which contains benzocaine gel, it's important to note that there is no specific information available about its safety during pregnancy. This means that the drug insert does not provide guidance on whether it is safe to use while pregnant, how the dosage might need to be adjusted, or if there are any special precautions you should take.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. There is a possibility that it can pass into your breast milk, which means it could affect your nursing infant. Since the effects of benzocaine on babies who are breastfed haven't been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

If your child is experiencing sore gums from teething, this medication can provide temporary relief for infants and children who are 4 months old and older. However, if your child is younger than 4 months, it’s important to consult with a doctor before using this product. Always ensure you follow the recommended guidelines for your child's age to keep them safe and comfortable.

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 safety considerations and monitoring practices for patients with renal impairment (kidney issues) are not detailed.

It's always best to consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can provide guidance tailored to your kidney health and any other medical needs you may have.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to be cautious when using this product, especially if your baby has a history of allergies to local anesthetics, such as procaine or butacaine, which are part of a group of medications known as "caine" anesthetics. If your baby has had any allergic reactions to these types of medications, you should avoid using this product and discuss alternatives with your healthcare provider.

While there are no specific interactions with other drugs or laboratory tests mentioned, it's always a good practice to talk to your healthcare provider about any medications or tests your baby may be undergoing. This ensures that you have the safest and most effective care tailored to your baby's needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 15 to 25°C (59-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

You should apply this topical product to the affected area up to four times a day, or as directed by your dentist or physician. It's important to avoid using it if your baby has a known allergy to local anesthetics, such as procaine or other "caine" anesthetics.

If your baby experiences fever and nasal congestion, these symptoms are not typical for teething and may suggest an infection; consult your physician if they persist. Additionally, if sore mouth symptoms do not improve within seven days, or if irritation, pain, redness, swelling, rash, or fever occurs, stop using the product and seek advice from a dentist or physician. Always keep this product out of reach of children, and in case of overdose or an allergic reaction, contact a Poison Control Center immediately.

FAQ

What is the purpose of this teething gel?

This teething gel temporarily relieves sore gums due to teething in infants and children 4 months and older.

How should I apply the teething gel?

Wash your hands and use your fingertip or a cotton applicator to apply a small pea-size amount to the affected area up to 4 times daily or as directed by a dentist or physician.

What should I do if my baby is under 4 months old?

For infants under 4 months of age, you should ask a doctor before using this product.

Are there any allergies I should be aware of?

Do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, or other 'caine' anesthetics.

What should I do if symptoms do not improve?

Stop using the gel and ask a dentist or physician if sore mouth symptoms do not get better in 7 days, or if irritation, pain, or redness persists.

Can I use this product for more than 7 days?

Do not use this product for more than 7 days unless directed by a physician.

What should I do in case of an overdose or allergic reaction?

In case of overdose or allergic reaction, contact a Poison Control Center right away.

Is it safe to use while nursing?

Nursing mothers should consult a physician before using this product, as there is a potential for excretion in breast milk.

What are the storage conditions for this teething gel?

Store the teething gel at 15 to 25°C (59-77°F).

Packaging Info

Below are the non-prescription pack sizes of Baby Teething Oral Pain Reliever (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Baby Teething Oral Pain Reliever.
Details

Drug Information (PDF)

This file contains official product information for Baby Teething Oral Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

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

Limitations of Use: This product is not intended for use in children under 4 months of age.

Dosage and Administration

Healthcare professionals are advised to ensure proper hand hygiene prior to the application of Budpack Baby Teething Gel Medicine. A small pea-sized amount of the gel should be applied to the affected area using either a fingertip or a cotton applicator.

The gel may be administered up to four times daily, or as directed by a dentist or physician. For infants under the age of 4 months, it is recommended to consult a doctor before use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used for more than 7 days unless directed by a physician. Additionally, it should not be used in excess of the recommended dosage.

Warnings and Precautions

The use of this product necessitates careful consideration of potential allergies and adverse reactions.

Allergy Alert This product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, or other "caine" anesthetics. Healthcare professionals should ensure that patients are screened for such allergies prior to administration.

Monitoring and Consultation Patients should be advised to discontinue use and consult a dentist or physician if any of the following conditions occur:

  • Symptoms of a sore mouth persist beyond 7 days.

  • Any irritation, pain, or redness does not resolve.

  • The patient experiences swelling, rash, or fever.

These symptoms may indicate a need for further evaluation and management.

Emergency Situations In the event of an overdose or suspected allergic reaction, immediate medical assistance is required. Patients or caregivers should contact a Poison Control Center without delay to ensure appropriate intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning includes an allergy alert; the product should not be used in patients with a history of allergy to local anesthetics, such as procaine, butacaine, or other "caine" anesthetics.

In clinical practice, patients are advised to discontinue use and consult a dentist or physician if any of the following occur: sore mouth symptoms that do not improve within 7 days, persistent irritation, pain, or redness, or the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and management.

Drug Interactions

The use of this product is contraindicated in patients with a known history of allergy to local anesthetics, specifically those classified as "caine" anesthetics, including procaine and butacaine.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, no additional monitoring or dosage adjustments are recommended based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Baby Teething Oral Pain Reliever (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Baby Teething Oral Pain Reliever.
Details

Pediatric Use

Pediatric patients aged 4 months and older may use this product for the temporary relief of sore gums associated with teething. For infants under 4 months of age, it is advised to consult a healthcare professional before use.

Geriatric Use

There is no specific information 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 regarding the use of Baby Teething Oral Pain Reliever - benzocaine gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the potential risks to fetal outcomes are not well characterized. It is advisable to weigh the benefits against any unknown risks when recommending this product to women of childbearing potential.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk. The effects of benzocaine on a nursing infant are not well studied; therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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 product out of reach of children. In the event of an overdose or allergic reaction, patients should be instructed to contact a Poison Control Center immediately.

Patients should be informed not to use the product for more than 7 days unless directed by a physician. It is important to emphasize that they should not exceed the recommended dosage.

Healthcare providers should counsel patients to discontinue use and consult a dentist or physician if sore mouth symptoms do not improve within 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if they experience irritation, pain, or redness that persists.

Patients should also be informed to stop using the product and consult a healthcare professional if they develop swelling, rash, or fever. It is crucial to explain that fever and nasal congestion are not typical symptoms of teething and may indicate an underlying infection. If these symptoms do not resolve, patients should be encouraged to contact their physician.

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 at a temperature range of 15 to 25°C (59 to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The product is administered topically, with application to the affected area allowed up to four times daily or as directed by a dentist or physician. Clinicians should counsel patients on specific allergy considerations, advising against use in infants with a history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics.

Patients should be informed that fever and nasal congestion are not typical symptoms of teething and may suggest an underlying infection; if these symptoms persist, they should consult a physician. Additionally, if sore mouth symptoms do not improve within seven days, or if irritation, pain, redness, swelling, rash, or fever develops, patients should discontinue use and seek advice from a dentist or physician. It is crucial to keep the product out of reach of children, and in cases of overdose or allergic reaction, immediate contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Baby Teething Oral Pain Reliever, 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 Baby Teething Oral Pain Reliever, 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.