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My Fair Baby

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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 2014
Label revision date
June 27, 2014
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 2014
Label revision date
June 27, 2014
Manufacturer
Delta Brands Inc
Registration number
part356
NDC root
20276-560
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

This medication is designed to provide temporary relief for sore gums caused by teething in children aged 2 years and older. Teething can be uncomfortable for little ones, and this product aims to help ease that discomfort, allowing them to feel more at ease during this developmental stage.

If your child is under 2 years of age, it's important to consult a physician or healthcare provider before using this medication to ensure it's appropriate for their needs.

Uses

If your child is experiencing sore gums from teething and is 2 years old or older, this product can provide temporary relief. It's important to note that if your child is under 2 years of age, you should consult a physician or healthcare provider before use.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. Always prioritize your child's health by seeking professional advice when needed.

Dosage and Administration

Before using the Oral Gel, make sure to wash your hands thoroughly. Then, take a small amount of the gel—about the size of a pea—and use your fingertip or a cotton applicator to gently spread it over the affected gums. You can apply the gel up to four times a day, or follow the instructions given by your physician or healthcare provider.

If you are considering this treatment for a child under the age of 2, it’s important to consult with a physician or healthcare provider first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never take more than the directed amount, as exceeding the recommended dosage can lead to unwanted effects. Additionally, avoid using this medication for more than 7 days unless your doctor or healthcare provider specifically instructs you to do so. Following these guidelines will help you use the medication safely and effectively.

Side Effects

If your baby has a history of allergies to local anesthetics, such as procaine or butacaine, it's important not to use this product. You should also stop using it and consult a physician if your baby’s sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists. Additionally, seek medical advice if your baby develops swelling, a rash, or a fever.

Warnings and Precautions

You should avoid using this product if your baby has ever had an allergy to local anesthetics, such as procaine or butacaine, which are often referred to as "caine" anesthetics.

If you suspect an overdose or notice any signs of an allergic reaction, it’s important to seek medical help immediately or contact a Poison Control Center. Additionally, if your baby’s sore mouth symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists, you should stop using the product and call your doctor. Be alert for any swelling, rash, or fever, as these may require immediate medical attention.

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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available in the drug insert. This means that there are no clear guidelines about whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for changing the dosage or taking special precautions if you are pregnant.

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

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor or healthcare provider before using this product. There is a possibility that the active ingredient, benzocaine, may pass into your breast milk, which means you should be cautious when considering its use. Currently, the safety of benzocaine for nursing mothers has not been fully established, so it's best to seek professional advice to ensure the well-being of both you and your baby.

Pediatric Use

If your child is 2 years old or older and experiencing sore gums from teething, this product can provide temporary relief. You can apply it to the affected area up to four times a day, or follow the instructions given by your healthcare provider.

However, if your child is under 2 years of age, it's important to consult a physician or healthcare provider before using this product. They can provide guidance on the best options for your little one.

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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to talk to your healthcare provider about any medications you or your baby are taking. If your baby has a history of allergies to local anesthetics, such as procaine or butacaine (often ending in "caine"), you should avoid using this product. This precaution helps prevent any serious allergic reactions.

While there are no specific interactions with other drugs or lab tests mentioned, discussing all medications and tests with your healthcare provider ensures safe and effective care. Always keep your provider informed about your baby's health history and any concerns you may have.

Storage and Handling

To ensure the best use of your product, store it at room temperature. It's important to check the tube before use: do not use it if the seal under the cap is broken, missing, or if the tip of the tube is cut before you open it. Following these guidelines will help maintain the product's integrity and safety for your use.

Additional Information

You should apply this product topically to the affected area up to four times a day, or as directed by your healthcare provider. It's important to note that if your baby has a history of allergies to local anesthetics like procaine or other "caine" anesthetics, you should not use this product.

While using this product, be aware that fever and nasal congestion are not typical signs of teething and could indicate an infection. If these symptoms persist, consult your physician. Additionally, if sore mouth symptoms do not improve within seven days, or if you notice irritation, pain, redness, swelling, rash, or fever, stop using the product and seek medical advice. In case of an overdose or allergic reaction, get medical help or contact a Poison Control Center immediately.

FAQ

What is this product used for?

This product is used for the temporary relief of sore gums due to teething in children 2 years of age and older.

Can I use this product for children under 2 years old?

For children under 2 years of age, you should consult a physician or healthcare provider before use.

How should I apply this product?

Wash your hands, then use your fingertip or a cotton applicator to apply a small pea-size amount of Oral Gel to the affected gums up to 4 times daily or as directed by a physician.

What should I do if symptoms do not improve?

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

Are there any allergy warnings?

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 in case of an overdose or allergic reaction?

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

Is this product safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, so consult a physician or healthcare provider.

Can nursing mothers use this product?

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

How should I store this product?

Store at room temperature and do not use if the tube seal under the cap is broken, missing, or if the tube tip is cut prior to opening.

Packaging Info

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

Packaging configurations for My Fair Baby.
Details

Drug Information (PDF)

This file contains official product information for My Fair Baby, 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.

Uses and Indications

This drug is indicated for the temporary relief of sore gums due to teething in children aged 2 years and older. For children under the age of 2, consultation with a physician or healthcare provider is recommended prior to use.

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

Dosage and Administration

Healthcare professionals are advised to follow the steps outlined below for the administration of the Oral Gel.

Prior to application, it is essential to wash hands thoroughly to maintain hygiene. A small pea-sized amount of the Oral Gel should be applied using either a fingertip or a cotton applicator. The gel should be evenly spread over the affected gums.

The recommended frequency of application is up to four times daily, or as directed by a physician or healthcare provider. For pediatric patients under the age of 2 years, it is imperative to consult a physician or healthcare provider before use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, do not use for more than 7 days unless directed by a physician or healthcare provider. Adherence to these guidelines is essential to prevent potential adverse effects associated with prolonged use.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is contraindicated in infants with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, or any other "caine" anesthetics. The potential for severe allergic reactions necessitates careful screening of patients prior to administration.

General Precautions In the event of an overdose or suspected allergic reaction, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management.

Monitoring and Follow-Up Patients should be closely monitored for the following symptoms, and if any of these conditions arise, it is crucial to stop the use of the product and consult a healthcare provider:

  • If sore mouth symptoms persist beyond 7 days.

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

  • If any swelling, rash, or fever develops.

Emergency Situations In cases of overdose or allergic reactions, it is essential to obtain emergency medical help promptly. Contacting a Poison Control Center is also recommended to facilitate timely intervention.

Side Effects

Patients should be aware of the potential for adverse reactions associated with this product. A significant allergy alert is noted: the product should not be used in patients with a history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics.

In clinical practice, it is advised that patients discontinue use and consult a 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 medical evaluation and intervention.

Drug Interactions

The use of this product is contraindicated in patients with a known history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics.

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

Packaging & NDC

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

Packaging configurations for My Fair Baby.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use this product for the temporary relief of sore gums due to teething. The recommended application is up to 4 times daily or as directed by a physician or healthcare provider.

For children under the age of 2, it is essential to consult a physician or healthcare provider prior to 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a physician or healthcare provider before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The safety of benzocaine in nursing mothers has not been established.

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 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care remain the cornerstones of effective management in overdose situations.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose or allergic reaction. It is important to instruct patients not to exceed the recommended dosage and to refrain from using the product for more than 7 days unless specifically directed by a physician or healthcare provider.

Patients should be informed to discontinue use and consult a physician if symptoms of a sore mouth do not improve within 7 days. Additionally, they should be advised to stop using the product and seek medical advice if they experience any irritation, pain, or redness that does not resolve. Patients should also be cautioned to stop use and contact a physician if they develop swelling, rash, or fever.

Furthermore, healthcare providers should emphasize that while using this product, fever and nasal congestion are not typical symptoms of teething and may suggest an underlying infection. If these symptoms persist, patients should be encouraged to consult their physician for further evaluation.

Storage and Handling

The product is supplied in a tube format. It should be stored at room temperature to maintain its efficacy. Healthcare professionals are advised to inspect the product prior to use; specifically, the tube should not be used if the seal under the cap is broken, missing, or if the tube tip is cut prior to opening. Proper handling and storage conditions are essential to ensure the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended application to the affected area up to four times daily or as directed by a physician or healthcare provider. Clinicians should counsel patients on specific precautions, including an allergy alert for those with a history of allergies to local anesthetics such as 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; persistent symptoms should prompt consultation with a physician. Additionally, if sore mouth symptoms do not improve within seven days, or if irritation, pain, redness, swelling, rash, or fever occurs, patients should discontinue use and seek medical advice. In cases of overdose or allergic reaction, immediate medical assistance or contact with a Poison Control Center is advised.

Drug Information (PDF)

This file contains official product information for My Fair Baby, 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 My Fair Baby, 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

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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.