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Dental Relief

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Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2016
Label revision date
February 27, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Drug class
Standardized Chemical Allergen
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 2016
Label revision date
February 27, 2014
Manufacturer
Cintas First Aid & Safety
Registration number
part356
NDC root
68421-8100
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Dental Relief is a topical medication that contains benzocaine (20%) and compound benzoin tincture. It is designed to provide temporary relief from pain associated with canker sores, minor mouth and gum injuries, and irritation caused by dentures or orthodontic appliances. This product can also help alleviate discomfort related to toothaches and minor dental procedures.

When you apply Dental Relief, it works by numbing the affected area, which helps to ease your pain and discomfort. It's important to remember that this relief is temporary, so if you have ongoing issues, you should consult a healthcare professional.

Uses

You can use this medication for temporary relief from minor pain and soreness in your mouth. It’s particularly helpful for discomfort associated with toothaches, minor dental procedures, and irritations caused by dentures or orthodontic appliances.

Additionally, if you have canker sores or minor injuries in your mouth and gums, this medication can provide temporary relief from the pain and irritation. It's designed to help you feel more comfortable while dealing with these common oral issues.

Dosage and Administration

To use this medication effectively, start by drying the affected area where you plan to apply it. You should apply the medication undiluted, which means you don’t need to mix it with anything else. For adults and children aged 2 years and older, you can use the medication up to four times a day, but make sure not to apply it more often than every two hours. If you have any questions or need specific guidance, it’s best to consult your dentist or doctor.

If you’re considering using this medication for a child under 2 years old, please consult a dentist or doctor first. Additionally, if the user is a child under 12 years old, it’s important that they are supervised while using the product to ensure safety and proper use.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than 7 days unless your dentist or doctor specifically instructs you to do so. Additionally, make sure not to exceed the recommended dosage, as doing so can lead to unwanted effects.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help you use it safely and effectively. Always consult with your healthcare provider if you have any questions or concerns.

Side Effects

You should be aware that this product is for oral use only. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics, it’s important not to use this product, as it could lead to a serious allergic reaction called anaphylaxis (a severe, potentially life-threatening allergic response).

While using this product, if your sore mouth symptoms do not improve within 7 days, or if you experience worsening irritation, pain, or redness, you should contact your doctor or dentist. Additionally, seek medical attention if you notice any swelling, rash, fever, or other signs of an allergic reaction.

Warnings and Precautions

This product is intended for oral use only. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics, you should not use this product, as it may cause a severe allergic reaction known as anaphylactic shock.

You should not use this product for more than 7 days unless your dentist or doctor advises you to do so. If your sore mouth symptoms do not improve within this time, or if you experience worsening irritation, pain, redness, swelling, rash, fever, or any other allergic reaction, please contact your doctor or dentist immediately. Always follow the recommended dosage, and if you accidentally swallow more than the intended amount, seek medical help or contact a Poison Control Center right away.

Overdose

If you accidentally swallow more of this medication than what is needed for pain relief and protection, it’s important to seek medical help immediately or contact a Poison Control Center. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may include unusual symptoms that could affect your breathing or overall well-being. If you notice any concerning changes in your health after taking the medication, it’s crucial to act quickly and reach out for help. Your safety is the top priority, so always err on the side of caution.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been evaluated. There are no specific contraindications (reasons not to use it) mentioned for pregnant individuals, but the safety of benzocaine, an ingredient in the product, has not been established. Therefore, it is crucial to consult your healthcare provider before using this product.

Additionally, there are no specific dosage adjustments recommended for pregnant individuals. To ensure your safety and the safety of your baby, it is best to speak with your dentist or doctor if you are pregnant before using this product.

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 associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering using this product for your child, it's important to consult a dentist or doctor if your child is under 2 years old. For children under 12, make sure they are supervised while using the product to ensure safety.

For children aged 2 years and older, you can apply the medication directly to the dry affected area without diluting it. You can use it up to four times a day, but be careful not to apply it more often than every two hours, unless directed otherwise by a healthcare professional.

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, it’s important to consult with a healthcare provider for personalized advice. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

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

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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's crucial to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. Using this product could lead to serious allergic reactions, including anaphylactic shock, which can be life-threatening.

While there are no specific interactions with other drugs or lab tests noted, it's always best to keep your healthcare provider informed about all your medications and any tests you may undergo. This ensures your safety and helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15° to 30°C (59° to 86°F). It's important to keep the product in a dry place and away from direct sunlight.

When handling the product, please check the packaging carefully. Do not use it if the packet is torn, cut, or opened, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the dry affected area, using it undiluted. For adults and children aged 2 years and older, you can use it up to four times a day, but not more frequently than every two hours, unless directed otherwise by a dentist or doctor. If you have a child under 2 years old, consult a dentist or doctor before use. Additionally, children under 12 should be supervised while using this product to ensure safety.

FAQ

What is Dental Relief used for?

Dental Relief is used for temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures, and irritations from dentures or orthodontic appliances.

What are the active ingredients in Dental Relief?

The active ingredients in Dental Relief are Benzocaine (20%) and Compound benzoin tincture.

How should I use Dental Relief?

For adults and children 2 years and older, 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 warnings associated with Dental Relief?

Yes, Dental Relief is for oral use only and should not be used if you have a history of allergy to local anaesthetics, such as procaine or benzocaine, due to the risk of anaphylactic shock.

What should I do if my symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your doctor or dentist promptly.

Can I use Dental Relief during pregnancy?

The safety of Dental Relief during pregnancy has not been established, so it is advised to consult a healthcare provider before use.

Is there any specific information for children using Dental Relief?

Consult a dentist or doctor for use on children under 2 years of age, and children under 12 years should be supervised while using this product.

What should I do if I accidentally swallow more than the recommended dose?

If more than the recommended dose is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store Dental Relief?

Store Dental Relief at room temperature, between 15° to 30°C (59° to 86°F), and do not use if the packet is torn, cut, or opened.

Packaging Info

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

Packaging configurations for Dental Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Benzocaine (20%) and compound benzoin tincture are the active ingredients in this formulation. The product is presented in a dosage form with a net weight of 0.5 grams. Benzocaine is a local anesthetic, while compound benzoin tincture serves as a topical protectant. The combination of these ingredients is intended for specific therapeutic applications.

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. It also provides temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor mouth and gum injuries.

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

Dosage and Administration

Adults and children aged 2 years and older should dry the affected area before applying the medication undiluted. The medication may be used up to four times daily, with applications not exceeding every two hours, unless otherwise directed by a dentist or doctor.

For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use. Additionally, children under 12 years should be supervised during the application of this product to ensure safe and effective use.

Contraindications

Use is contraindicated in patients who require treatment for longer than 7 days unless directed by a dentist or doctor. Additionally, exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

Warnings and Precautions

Oral use of this product is strictly indicated. It is imperative that this product not be administered to individuals with a known history of allergy to local anaesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anaesthetics, due to the risk of anaphylactic shock.

The duration of use should not exceed 7 days unless specifically directed by a dentist or physician. In cases where symptoms of a sore mouth do not show improvement within this timeframe, or if there is a persistence or worsening of irritation, pain, or redness, it is essential to seek prompt medical attention from a healthcare professional. Additionally, any development of swelling, rash, fever, or other signs of an allergic reaction warrants immediate consultation with a doctor or dentist.

Healthcare professionals should ensure that patients do not exceed the recommended dosage. In the event that the product is accidentally ingested in excess of the intended use for pain relief and protection, it is critical to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for oral use only. It is contraindicated in individuals with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, due to the risk of anaphylactic shock.

During the use of this product, if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients are advised to seek medical attention from a doctor or dentist promptly. Additionally, if any signs of swelling, rash, fever, or other allergic reactions develop, immediate consultation with a healthcare professional is recommended.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of this product due to the risk of anaphylactic shock.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Dental Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a dentist or doctor prior to using this product. For children under 12 years of age, supervision is recommended during use.

For children aged 2 years and older, the affected area should be dried before applying the medication undiluted. The product may be used up to 4 times daily, but not more frequently than every two hours, unless otherwise directed by a dentist or doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. There are no specific contraindications mentioned for its use in pregnant patients; however, the safety of benzocaine during pregnancy has not been established. Therefore, it is essential for women of childbearing potential to consult a healthcare provider before using this product. No specific dosage modifications for pregnant individuals are provided. Special precautions should be taken, and it is advised that pregnant patients consult a dentist or doctor prior to use.

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 during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding the recommended dosage for pain relief and protection is ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and the clinical presentation can range from mild to severe.

Management procedures should include thorough assessment and monitoring of the patient’s condition. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance and the severity of the symptoms.

It is imperative that healthcare providers remain vigilant and prepared to act swiftly in the event of an overdosage to ensure optimal patient outcomes.

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 seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for pain relief and protection is accidentally swallowed.

Patients should be informed not to use the product for more than 7 days unless specifically directed by a dentist or doctor. It is important to communicate that if symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, patients should promptly consult their doctor or dentist. Additionally, patients should be made aware that they must not exceed the recommended dosage to avoid potential adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a temperature range of 15° to 30°C (59° to 86°F).

Healthcare professionals should ensure that the product is not used if the packet is torn, cut, or opened, as this may compromise the integrity and safety of the contents. Proper handling and storage conditions are crucial to maintaining the product's efficacy.

Additional Clinical Information

The medication is administered topically, with instructions for adults and children aged 2 years and older to dry the affected area and apply the medication undiluted. It may be used up to four times daily, but not more frequently than every two hours, unless otherwise directed by a dentist or doctor. Clinicians should advise patients to consult a dentist or doctor before using the product on children under 2 years of age. Additionally, children under 12 years should be supervised during the use of this product.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dental 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 Dental 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.

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.