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Brace Relief

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Active ingredient
Benzocaine 9 mg/1 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Gel
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2005
Label revision date
January 16, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 9 mg/1 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Gel
Route
Oral
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 2005
Label revision date
January 16, 2026
Manufacturer
InfaLab, Inc
Registration number
M004
NDC root
60306-115
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

INfALAB® MAGIC TOUCH BraceRelief™ is an anesthetic gel designed to help relieve mouth pain. It comes in an antiseptic base, which means it not only numbs the area but also helps keep it clean. This product is particularly useful for individuals experiencing discomfort, possibly due to dental work or braces.

With a net weight of 3 grams, this gel is easy to apply and can provide quick relief when you need it most. If you're looking for a way to soothe mouth pain, INfALAB® MAGIC TOUCH BraceRelief™ may be a helpful option for you.

Uses

You can use this medication to help relieve mouth pain. It is designed to provide comfort and ease discomfort in your mouth, making it easier for you to go about your daily activities. There are no known effects that could harm a developing fetus, so it is considered safe in that regard. If you're experiencing mouth pain, this medication may be a suitable option for you.

Dosage and Administration

You can apply this medication to any irritated areas of your skin as needed. It's important to follow the specific instructions provided in the package insert, which includes important warnings and cautions to ensure your safety while using the product. Always make sure to read through these details carefully before application to understand how to use it properly.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would make the drug unsafe for you) or controlled substance classifications associated with it. This means that there are no known risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance) linked to this medication.

Since there are no "do not take" or "do not use" instructions provided, you can proceed with its use as directed by your healthcare provider. Always remember to discuss any concerns or questions with them to ensure the best outcomes for your health.

Side Effects

When using this medication, it's important to remember that it is intended for temporary relief only. This means that while it can help alleviate symptoms, it should not be used as a long-term solution. If you experience any side effects or if your symptoms persist, please consult your healthcare provider for further guidance.

Warnings and Precautions

This medication is intended for temporary relief only. It’s important to use it as directed and not rely on it for long-term treatment.

If you experience any unusual symptoms or if your condition does not improve, stop taking the medication and call your doctor for further guidance. Always prioritize your health and seek medical advice when needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. In fact, benzocaine is contraindicated during pregnancy due to potential risks to your developing baby, which may include adverse effects on fetal development.

Before using benzocaine, you should always consult your healthcare provider. While there are no specific dosage modifications for pregnant individuals, caution is strongly advised. Prioritizing your health and the health of your baby is essential, so make sure to discuss any medications with your doctor.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and provide personalized advice to ensure the health and safety of both you and your infant.

Pediatric Use

The information provided does not specifically address the use of this medication in children. There are no recommended ages, dosage differences, or safety concerns outlined for pediatric use. As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication in children, as they can provide tailored advice based on your child's specific needs.

Geriatric Use

When considering Brace Relief (benzocaine gel) for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

As you or your loved ones explore options for pain relief, it’s always a good idea to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

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 related to 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 plan.

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 determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, please remember to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is INfALAB® MAGIC TOUCH BraceRelief™?

INfALAB® MAGIC TOUCH BraceRelief™ is an anesthetic gel in an antiseptic base that relieves mouth pain.

How should I use BraceRelief™?

Apply the gel to irritated areas as needed. Refer to the package insert for detailed instructions, warnings, and cautions.

Are there any contraindications for using BraceRelief™?

There are no contraindications listed for BraceRelief™.

Is BraceRelief™ safe to use during pregnancy?

The safety of benzocaine, the active ingredient, during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if I experience mouth pain?

You can use BraceRelief™ for temporary relief of mouth pain, but consult a healthcare provider if symptoms persist.

How should I store BraceRelief™?

Store the gel at room temperature, protect it from light, and do not freeze. Discard it after opening.

Are there any warnings associated with BraceRelief™?

BraceRelief™ is intended for temporary relief only.

Can children use BraceRelief™?

The provided text does not address pediatric use, so consult a healthcare provider for guidance.

Is there any information about nursing mothers using BraceRelief™?

There are no specific statements regarding the use of BraceRelief™ by nursing mothers in the provided text.

Packaging Info

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

Packaging configurations for Brace Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of mouth pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to apply the product to irritated areas as needed. It is essential to refer to the package insert for detailed instructions, warnings, and cautions associated with the use of this product. Proper adherence to these guidelines will ensure safe and effective administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For temporary relief only. Healthcare professionals should advise patients that the product is intended solely for short-term use and is not a substitute for comprehensive medical evaluation or treatment.

In the event of adverse reactions or unexpected symptoms, patients are instructed to discontinue use immediately and consult their healthcare provider for further guidance. It is essential to monitor patients for any signs of complications or worsening conditions during the use of this product.

Emergency medical assistance should be sought if patients experience severe or concerning symptoms that may indicate a serious reaction.

Side Effects

Patients should be aware that the use of this medication is intended for temporary relief only. It is important to monitor for any adverse reactions that may arise during treatment.

In clinical trials, participants reported various adverse reactions, although specific frequency data was not provided. Postmarketing experiences have also indicated that some patients may encounter unexpected side effects.

Healthcare providers should ensure that patients are informed about the potential for adverse reactions and the importance of using the medication as directed for temporary relief. Regular follow-up may be necessary to assess the patient's response to treatment and to manage any adverse effects that may occur.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Brace Relief.
Details

Pediatric Use

Pediatric use has not been specifically addressed in the provided information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of available data.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Brace Relief (benzocaine gel). As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any adverse effects or unusual responses to treatment, given the lack of targeted data for this demographic.

Pregnancy

The safety of benzocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks, including potential adverse effects on fetal development. While no specific dosage modifications for pregnant individuals are provided, caution is advised when considering the use of benzocaine. Pregnant women are encouraged to consult a healthcare provider prior to using benzocaine to discuss potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 safeguarding medications to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Brace Relief, 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 Brace Relief, 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.