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Oral Pain Relief Gel

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Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2022
Label revision date
January 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2022
Label revision date
January 15, 2024
Manufacturer
Sled Distribution, LLC
Registration number
M017
NDC root
81417-001
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

You may find this medication helpful for the temporary relief of minor pain and soreness in your mouth. It is commonly used for issues related to toothaches, minor dental procedures, and irritations caused by dentures or orthodontic appliances. This means that if you're experiencing discomfort in these areas, this medication can provide some comfort and ease your symptoms.

Uses

You can use this medication for the temporary relief of minor pain and discomfort in your mouth. It is particularly helpful for issues like toothaches, minor dental procedures, and irritations caused by dentures or orthodontic appliances.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this medication effectively, start by drying the affected area of your skin. Then, apply the medication directly onto that area without diluting it. You can use this treatment up to four times a day, but make sure not to apply it more often than every two hours. If you have any specific instructions from your dentist or doctor, be sure to follow those as well.

This medication is meant for topical application, which means you will be putting it directly on your skin rather than taking it by mouth or injecting it. Always remember to keep the area dry before applying the medication for the best results.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with it, you should stop using the medication and consult your doctor if you experience any discomfort. Your health and safety are paramount, so don't hesitate to reach out for guidance if needed.

Side Effects

It's important to be aware of potential side effects when using this medication. If you experience any discomfort while taking it, you should stop using it and consult your doctor for further guidance.

Remember, this medication is intended for oral use only, so ensure you follow this guideline to avoid any complications.

Warnings and Precautions

This medication is intended for oral use only, so please ensure you take it as directed. If you experience any discomfort while using this medication, it’s important to stop taking it and consult your doctor for further guidance.

While there are no specific laboratory tests or emergency help instructions associated with this medication, always prioritize your health and reach out to a healthcare professional if you have any concerns.

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, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always remember that when in doubt, it's better to err on the side of caution and seek professional assistance.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns provided. It's important to consult with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

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. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

When using this medication for children aged 2 years and older, you should first dry the affected area before applying the medication directly without diluting it. You can use it up to four times a day, but make sure not to apply it more often than every two hours unless directed otherwise by a dentist or doctor.

It's very important to keep this medication out of reach of children to ensure their safety. Always follow the guidance provided by healthcare professionals regarding its use.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this medication?

This medication provides temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures, and irritations from dentures or orthodontic appliances.

What is the recommended dosage for adults and children 2 years and older?

You should dry the affected area and apply the medication undiluted, up to 4 times daily but not more than every two hours, or as directed by a dentist or doctor.

Are there any contraindications for this medication?

No contraindications are listed for this medication.

What should I do if I experience discomfort while using this medication?

You should stop use and ask a doctor if you experience any discomfort.

Is this medication safe for use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this product in pregnancy or nursing mothers.

How should I store this medication?

Store the medication at room temperature and keep it out of reach of children. Discard after opening.

What is the method of application for this medication?

The medication should be applied topically, undiluted, to the dry affected area.

Is there any information on drug interactions?

No specific drug interactions are mentioned for this medication.

Packaging Info

Below are the non-prescription pack sizes of Oral Pain Relief Gel (benzocaine 20%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a sterile, non-pyrogenic solution that is clear and colorless to slightly yellow in appearance. Each milliliter contains 10 mg of the active ingredient, along with 0.9% sodium chloride to ensure isotonicity, and water for injection, USP, to a total volume of 1 mL. The pH of the solution is adjusted to a range of 4.5 to 7.0 using hydrochloric acid and/or sodium hydroxide. It is packaged in a single-dose vial, with inactive ingredients comprising sodium chloride and water for injection. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures, and irritations from dentures or orthodontic appliances.

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication undiluted to the dry affected area. The medication may be used up to four times daily, ensuring that applications do not occur more frequently than every two hours, unless otherwise directed by a dentist or physician.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any discomfort occurs.

Warnings and Precautions

For oral use only. Healthcare professionals should ensure that patients are aware of this route of administration to prevent misuse.

Patients are advised to discontinue use and consult a healthcare provider if they experience any discomfort. Monitoring for adverse effects is essential to ensure patient safety and effective management of any potential reactions.

Side Effects

Patients should be aware that this product is intended for oral use only. In the event of any discomfort, it is advised to stop use and consult a healthcare professional.

While specific adverse reactions have not been detailed in the provided information, it is important for patients to monitor their health and report any unexpected symptoms to their healthcare provider.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Oral Pain Relief Gel (benzocaine 20%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Pain Relief Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older should have the affected area dried before applying the medication undiluted. The medication may be used up to four times daily, but not more frequently than every two hours, unless otherwise directed by a dentist or a doctor.

It is important to keep the medication out of reach of children to prevent accidental ingestion or misuse.

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

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no specific data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is essential to exercise caution and to monitor any developments closely in pregnant patients receiving this treatment.

Lactation

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

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 clinical scenario and the substance involved. 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 substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the necessity of stopping the use of the medication and consulting a doctor if they experience any discomfort. This guidance ensures that patients are aware of the potential risks and the importance of seeking medical advice when needed.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper handling and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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.