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Atopalm Oral Pain Relief

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This product has been discontinued

Active ingredient
Benzocaine 10 g/100 g
Other brand names
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 2012
Label revision date
February 6, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 10 g/100 g
Other brand names
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 2012
Label revision date
February 6, 2012
Manufacturer
NeoPharm, USA
Registration number
part356
NDC root
51141-0236
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

ATOPALM Oral Pain Relief Gel is a topical medication designed to provide fast temporary relief from pain caused by toothaches. It contains benzocaine (a local anesthetic that numbs the area) at a concentration of 10%, helping to alleviate discomfort effectively. This product is distributed by NeoPharm USA and is manufactured in Korea, ensuring quality and reliability for those seeking relief from dental pain.

Uses

If you're experiencing a toothache, this medication can provide you with temporary relief from the pain. It's designed to help you feel better quickly, allowing you to manage discomfort until you can see a dentist.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

To use this product effectively, you should apply a small amount directly into the cavity and around the gums surrounding your teeth. This can be done up to four times a day, or as your dentist or doctor advises.

If you are using this product for a child under 12 years old, it's important that they are supervised during application to ensure safety. For children younger than 2 years, you should consult with a dentist or doctor before use to get specific guidance.

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 this can lead to unwanted effects. Additionally, avoid using the medication for more than 7 days unless your dentist or doctor specifically advises you to do so. Following these guidelines will help you use the medication safely and effectively.

Side Effects

If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. It's important to follow the directions carefully and not use it for more than 7 days unless your dentist or doctor advises otherwise.

You should stop using the product and consult a doctor if you experience any swelling, rash, or fever, or if irritation, pain, or redness continues or worsens.

Warnings and Precautions

You should avoid using this product if you have ever had an allergic reaction to local anesthetics, such as procaine, butacaine, benzocaine, or any other “caine” anesthetics. It’s important to follow the directions carefully—do not use more than recommended and do not use it for longer than 7 days unless your dentist or doctor advises you to do so.

If you experience any swelling, rash, or fever, or if irritation, pain, or redness continues or gets worse, stop using the product and call your doctor. In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution; if you notice anything concerning after taking medication, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

Pregnancy Use

Currently, there is no information available about the use of ATOPALM Oral Pain Relief (benzocaine gel) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

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 are no concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

When using this product for children, it's important to supervise those under 12 years of age to ensure safety. If your child is under 2 years old, you should consult a dentist or doctor before use. For children aged 2 years and older, you can apply a small amount of the product directly to the cavity and around the gums. This can be done up to four times a day or as directed by a healthcare professional. Always follow these guidelines to help keep your child safe and healthy.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep your doctor informed about any other medications or health conditions, as this can help ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 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 monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be aware of potential interactions when considering any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other "caine" anesthetics, you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests mentioned, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the safe use of your product, it's important to handle it carefully. First, do not use the product if the tube tip is cut before you open it, as this could compromise its safety and effectiveness.

When storing the product, keep it in a cool, dry place to maintain its integrity. Always check the packaging for any specific storage instructions to ensure optimal performance. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is ATOPALM Oral Pain Relief Gel used for?

ATOPALM Oral Pain Relief Gel is used for the fast temporary relief of pain due to toothaches.

What is the active ingredient in ATOPALM Oral Pain Relief Gel?

The active ingredient is benzocaine at a concentration of 10%.

Who can use ATOPALM Oral Pain Relief Gel?

Adults and children 2 years of age and older can use it, while children under 12 should be supervised, and those under 2 should consult a dentist or doctor.

How should I apply ATOPALM Oral Pain Relief Gel?

Apply a small amount of the gel to the cavity and around the gum surrounding the teeth, up to 4 times daily or as directed by a dentist or doctor.

Are there any contraindications for using ATOPALM Oral Pain Relief Gel?

Yes, do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

What should I do if I experience swelling, rash, or fever while using this product?

Stop using the product and call your doctor if swelling, rash, or fever develops, or if irritation, pain, or redness persists or worsens.

Can I use ATOPALM Oral Pain Relief Gel for more than 7 days?

No, do not use it for more than 7 days unless directed by a dentist or doctor.

Is there any information regarding the use of ATOPALM Oral Pain Relief Gel during pregnancy or lactation?

There is no specific information regarding its use during pregnancy or lactation in the provided insert.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Atopalm Oral Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ATOPALM Oral Pain Relief Gel is formulated to provide fast temporary relief of pain associated with toothache. The active ingredient, benzocaine, is present at a concentration of 10%. This product is distributed by NeoPharm USA, located at 1 Oyster Bay Drive, Rumson, NJ 07760, and is manufactured in Korea.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with toothaches. It provides fast temporary relief of pain due to toothache.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the cavity and around the gums surrounding the teeth. This application may be performed up to four times daily or as directed by a dentist or physician.

Children under 12 years of age should be supervised during the use of this product to ensure proper application and safety.

For children under 2 years of age, it is recommended to consult a dentist or physician prior to use to determine the appropriateness of the product.

Contraindications

Use of this product is contraindicated in patients who exceed the directed dosage or utilize it for more than 7 days without the guidance of a dentist or physician. Adherence to these instructions is essential to prevent potential adverse effects associated with prolonged use.

Warnings and Precautions

The use of this product is contraindicated in individuals with a known allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics.

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and duration of use. The product should not be used for more than 7 days unless specifically directed by a dentist or physician.

Patients should be instructed to discontinue use and seek medical attention if they experience any of the following symptoms: swelling, rash, or fever. Additionally, if irritation, pain, or redness persists or worsens, it is imperative to consult a healthcare provider.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

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

It is important for patients to adhere to the recommended usage guidelines. The product should not be used more than directed or for a duration exceeding 7 days unless specifically instructed by a dentist or doctor.

Patients are advised to discontinue use and consult a healthcare professional if they experience any of the following: swelling, rash, or fever; or if irritation, pain, or redness persists or worsens. These reactions may indicate a need for medical evaluation.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other agents within the "caine" class.

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 Atopalm Oral Pain Relief (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Atopalm Oral Pain Relief.
Details

Pediatric Use

Children under 12 years of age should be supervised when using this product to ensure safe application. For children under 2 years of age, it is recommended to consult a dentist or a doctor prior to use.

For pediatric patients aged 2 years and older, a small amount of the product should be applied to the cavity and around the gums surrounding the teeth. This can be done up to 4 times daily or as directed by a dentist or a doctor.

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 currently no information available regarding the use of ATOPALM Oral Pain Relief (benzocaine gel) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. 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 to do so by a dentist or a doctor.

Patients should be informed to discontinue use and consult a healthcare professional if they experience any swelling, rash, or fever. Additionally, they should be instructed to stop using the product and seek medical advice if they notice any irritation, pain, or redness that persists or worsens.

Storage and Handling

The product is supplied in a tube format. It is imperative that the tube is not used if the tip has been cut prior to opening, as this may compromise the integrity of the product.

For optimal storage and handling, the product should be kept in a controlled environment, away from extreme temperatures and direct sunlight. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Atopalm Oral Pain 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 Atopalm Oral Pain 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.

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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.