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My Fair Baby Oral Gel

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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
December 20, 2020
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
December 20, 2020
Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Registration number
part356
NDC root
47046-180
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 medication 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 using this product.

This medication is specifically designed to help ease the discomfort associated with teething, making it a helpful option for parents looking to soothe their little ones during this challenging time.

Dosage and Administration

Before using the Oral Gel, make sure to wash your hands thoroughly to keep everything clean. 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 area of your gums.

You can apply the gel up to four times a day, or as your doctor or healthcare provider advises. If you are considering this treatment for a child under 2 years old, it’s important to consult with a physician or healthcare provider first to ensure it’s safe 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 like procaine or butacaine, it's important not to use this product. You should also stop using it and consult a doctor 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 allergic reaction 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 emergency medical help immediately or contact a Poison Control Center.

Additionally, you should stop using the product and call your doctor if your baby’s sore mouth symptoms do not improve within 7 days, if there is ongoing irritation, pain, or redness, or if any swelling, rash, or fever occurs.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of MY FAIR BABY ORAL GEL (benzocaine gel) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how this product may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter products like this gel. They can help you weigh the potential risks and benefits based on your individual circumstances.

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 it could be passed into your breast milk, and the effects on nursing infants have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of 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 doctor or 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

While there is no specific information about the use of this product in older adults, it is important to note that it is designed for children aged 2 years and older. If you are caring for an older adult, you can feel reassured that there are no special dosage adjustments or safety concerns mentioned for this age group. However, as always, it’s wise to consult with a physician or healthcare provider if you have any questions or concerns about using this product.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

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 performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness.

When handling the product, be cautious not to 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 ensure your safety and the product's reliability.

Additional Information

You should apply the medication topically to the affected area up to four times a day, or as directed 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 healthcare professional first.

Be aware that if you experience symptoms like a sore mouth that doesn't improve after 7 days, or if you notice irritation, pain, redness, swelling, rash, or fever, you should stop using the medication and contact your physician. Additionally, if you have fever and nasal congestion, these could be signs of an infection, so it's best to seek medical advice if these symptoms persist.

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?

If sore mouth symptoms do not get better in 7 days, or if irritation, pain, or redness persists, you should stop use and consult a physician.

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 immediately.

Is this product safe to use while nursing?

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

How should I store this product?

Store the product at 20°C to 25°C (68°F to 77°F) and protect it from light. Do not use if the tube seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for My Fair Baby Oral Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 mentioned in the available data.

Dosage and Administration

Healthcare professionals are advised to follow the outlined procedures for the administration of the Oral Gel. Prior to application, it is essential to wash hands thoroughly to ensure hygiene.

A small pea-sized amount of the Oral Gel should be applied using either a fingertip or a cotton applicator. The gel must be spread evenly over the affected gums. This application can be performed 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 administration 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

Patients with a history of allergy to local anesthetics, including procaine, butacaine, or other "caine" anesthetics, should not use this product. The potential for severe allergic reactions necessitates careful consideration of the patient's medical history prior to administration.

In the event of an overdose or an allergic reaction, immediate medical assistance is required. Healthcare professionals should advise patients or caregivers to contact emergency medical services or a Poison Control Center without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: sore mouth symptoms persist beyond 7 days, irritation, pain, or redness does not resolve, or if there is the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. A significant warning is the allergy alert; 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, patients are advised to discontinue use and consult a physician if sore mouth symptoms do not improve within 7 days. Additionally, if irritation, pain, or redness persists, or if any swelling, rash, or fever develops, medical advice should be sought promptly. These recommendations are crucial for ensuring patient safety and addressing any serious reactions that may arise during treatment.

Drug Interactions

The use of this product is contraindicated in patients with a known history of allergy to local anesthetics, including but not limited to 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 in relation to drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for My Fair Baby Oral Gel.
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

Elderly patients may use this product; however, no specific information regarding geriatric use is provided in the prescribing information. The product is primarily intended for use in children aged 2 years and older, and it is recommended that a physician or healthcare provider be consulted for children under 2 years of age.

There are no dosage adjustments, safety concerns, or special precautions specifically mentioned for elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this product to geriatric patients, considering individual health status and potential comorbidities. Regular monitoring may be prudent to ensure safety and efficacy in this population.

Pregnancy

There are no specific statements regarding the use of MY FAIR BABY ORAL GEL (benzocaine gel) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks to pregnant patients and fetal outcomes remain undefined. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks before recommending this product during pregnancy.

Lactation

Lactating mothers should consult a physician or healthcare provider before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 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 emphasize that patients should not exceed the recommended dosage and should refrain from using the product for more than 7 days unless specifically directed by a physician or healthcare provider.

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

Healthcare providers should highlight that while using this product, symptoms such as fever and nasal congestion are not typical indicators 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 configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy and safety.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is imperative that the product is not used if the tube seal under the cap is broken, missing, or if the tube tip is cut prior to opening, as this may compromise the integrity of the product. Proper adherence to these storage and handling guidelines is essential for maintaining product quality.

Additional Clinical Information

The medication is administered topically, with application to the affected area permitted up to four times daily or as directed by a physician or healthcare provider. Clinicians should advise patients to consult a physician for children under the age of 2. If patients experience fever and nasal congestion, which may suggest an infection, they should seek medical advice if these symptoms persist. Additionally, patients are instructed to discontinue use and consult a physician if sore mouth symptoms do not improve within 7 days, or if they experience irritation, pain, redness, swelling, rash, or fever.

Drug Information (PDF)

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