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Baby Anestenka

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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
Registration number
part356
NDC root
53145-902
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

Baby Anestenka is a medication designed to temporarily relieve sore gums in infants and children who are 4 months of age and older. It is commonly used during the teething process, which can cause discomfort for young children as their teeth begin to emerge. This product aims to provide soothing relief to help ease the discomfort associated with teething.

Uses

If your child is experiencing sore gums from teething, this medication can help provide temporary relief. It is suitable for infants and children who are at least 4 months old. You can use it to soothe their discomfort during this challenging time.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safe option for your little one.

Dosage and Administration

Before using this medication, make sure to wash your hands thoroughly. Start by removing the safety seal from the bottle. You will need to apply 2 to 4 drops using your fingertip or a cotton swab directly to the affected area. You can do this up to four times a day, but be sure to follow your physician's instructions if they provide specific guidance.

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 advised and supervised by a dentist or physician. Always remember to use this medication only as directed to ensure safety and effectiveness.

What to Avoid

It's important to be aware of certain situations where you should stop using this product and consult a doctor or dentist. If your oral pain does not improve within 7 days, or if you experience ongoing irritation, pain, or redness, you should seek medical advice. Additionally, if you develop a rash, fever, or notice any redness or swelling, it's crucial to stop using the product and talk to a healthcare professional.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize your health and safety by following these guidelines. Your well-being is the most important consideration.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butaine, benzocaine, or other "caine" anesthetics, it's important not to use this product. Additionally, if you or your child experiences fever and nasal congestion, these symptoms are not typical of teething and may suggest an infection. Persistent fever could indicate a more serious condition, so it's advisable to consult your doctor or dentist if these symptoms occur.

Warnings and Precautions

This product is intended for oral use only. If you have a history of allergies to local anesthetics, such as procaine, butaine, benzocaine, or other "caine" anesthetics, you should not use this product. Be aware that fever and nasal congestion are not typical signs of teething and may indicate an infection. If these symptoms persist, it’s important to consult your doctor or dentist, as a fever could signal a serious condition.

To ensure safety, keep this product out of reach of children. If an accidental overdose occurs, seek medical help or contact a Poison Control Center immediately. You should stop using this product and call your doctor or dentist if your oral pain does not improve within 7 days, if you experience ongoing irritation, pain, or redness, or if you develop a rash or fever. Additionally, if you notice any redness or swelling, it’s important to reach out to a healthcare professional.

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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product has not been established. Benzocaine, a key ingredient, is not recommended for use during pregnancy due to potential risks to your developing baby. There may be specific risks associated with its use, so it's crucial to consult your healthcare provider for personalized advice.

Additionally, if you are pregnant, you may need to adjust the dosage of this product, and you should only use it if directed by a healthcare professional. Always prioritize your health and the health of your baby by seeking guidance from your doctor before using any medication.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. This means that, based on current knowledge, you can use this product without concern for its effects on your milk production or your baby.

Pediatric Use

You can use this medication to help temporarily relieve sore gums caused by teething in infants and children who are 4 months old and older. 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 the safety and well-being of 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 15°C and 30°C (59°F to 86°F). This temperature range helps maintain the product's quality. Before using, always check that the safety seal over the bottle cap is intact; do not use the product if the seal is torn, broken, or missing, as this could indicate contamination or that the product is no longer safe to use.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is Baby Anestenka used for?

Baby Anestenka is used to temporarily relieve sore gums due to teething in infants and children 4 months of age and older.

Are there any contraindications for using Baby Anestenka?

You should not use Baby Anestenka if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine, or other 'caine' anesthetics.

What should I do if my child's oral pain does not improve?

Stop use and consult a doctor or dentist if oral pain does not get better in 7 days, or if irritation, pain, or redness persists.

Can I use Baby Anestenka 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 Baby Anestenka?

Keep Baby Anestenka out of reach of children and do not use if the imprinted safety seal is torn, broken, or missing.

Is Baby Anestenka safe to use during pregnancy?

The safety of Baby Anestenka during pregnancy has not been established, and it is advised to avoid using it unless directed by a healthcare professional.

What should I do in case of accidental overdose?

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately.

What are the storage conditions for Baby Anestenka?

Store Baby Anestenka at a controlled room temperature between 15°C and 30°C (59°F to 86°F).

Packaging Info

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

Packaging configurations for Baby Anestenka.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Baby Anestenka is a topical anesthetic formulated for local anesthesia. The active ingredient in this preparation is Lidocaine. It is presented in a cream dosage form, characterized by a white to off-white color and a smooth texture. The formulation includes several inactive ingredients: Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Methylparaben, Propylparaben, and Sodium Hydroxide.

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.

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

Dosage and Administration

Healthcare professionals should instruct patients to adhere strictly to the recommended dosage and administration guidelines.

Prior to application, patients must wash their hands thoroughly. The imprinted safety seal on the bottle should be removed before use. Using a fingertip or a cotton swab, patients should apply 2 to 4 drops of the product directly to the affected area. This application may be performed up to four times daily, or as directed by a physician.

For infants under 4 months of age, no dosage or treatment is recommended unless advised and supervised by a dentist or physician.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

  • Oral pain persists for more than 7 days.

  • Irritation, pain, or redness does not resolve.

  • A rash or fever develops.

  • Redness or swelling is observed.

These recommendations are made to ensure patient safety and to address potential complications.

Warnings and Precautions

For oral use only. This product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butaine, benzocaine, or other "caine" anesthetics.

Fever and nasal congestion should not be attributed to teething, as these symptoms may indicate an underlying infection. If fever or nasal congestion persists, it is imperative to consult a healthcare professional, as a fever could signify a serious condition.

General precautions must be observed. This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: oral pain that does not improve within 7 days, persistent irritation, pain, or redness, the development of a rash or fever, or the presence of redness or swelling.

In cases of accidental overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Individuals with a history of allergy to local anesthetics, including procaine, butaine, benzocaine, or other "caine" anesthetics, should not use this product due to the risk of serious allergic reactions.

Commonly reported symptoms that may arise during use include fever and nasal congestion. It is important to note that these symptoms are not indicative of teething and may suggest the presence of an underlying infection. If fever and nasal congestion persist, patients are advised to consult their doctor or dentist, as a fever could be a sign of a serious condition requiring medical attention.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Baby Anestenka.
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 younger than 4 months, no dosage or treatment is recommended unless advised and supervised by a dentist or physician.

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.

Pregnancy

The safety of this product during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of benzocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice.

Dosage adjustments may be necessary for pregnant individuals, and medical guidance should be sought before use. Pregnant women should avoid using this product unless directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 excessive dosing. Symptoms of overdosage 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.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management 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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal over the bottle cap. It is essential to ensure that this seal is intact prior to opening; do not use the product if the seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a controlled room temperature ranging from 15°C to 30°C (59°F to 86°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Baby Anestenka, 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 Anestenka, 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.