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Mouth Sore Medication

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
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 2010
Label revision date
June 23, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
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 2010
Label revision date
June 23, 2014
Manufacturer
Zee Medical
Registration number
part356
NDC root
35418-631
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

MOUTH SORE ZEE is an oral pain reliever designed to provide temporary relief from various types of mouth discomfort. It can help alleviate pain caused by toothaches, canker sores, gum sores, dental work, cheek bites, denture irritation, and minor injuries or irritations of the mouth and gums.

This medication is formulated for fast relief, making it a convenient option for managing oral pain. If you're experiencing any of the mentioned issues, MOUTH SORE ZEE may be a helpful choice to ease your discomfort.

Uses

If you're experiencing discomfort in your mouth, this medication can help temporarily relieve pain from various sources. It’s effective for toothaches, canker sores, gum sores, and discomfort following dental work. You can also use it for pain caused by cheek bites, denture irritation, or minor injuries and irritations in the mouth and gums.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus.

Dosage and Administration

To use this medication effectively, start by drying the affected area where you plan to apply it. You can apply the medication up to four times a day, but make sure not to use it more frequently than every two hours unless your dentist or doctor advises otherwise.

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

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 potential risks.

By following these guidelines, you can help prevent any adverse effects and ensure that the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of some key warnings and allergy alerts associated with this product. This medication is intended for oral use only, so please avoid using it in any other way. Additionally, be careful to keep it away from your eyes to prevent irritation.

If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other anesthetics that end with “caine,” you should not use this product. Always consult with a healthcare professional if you have concerns about potential allergic reactions.

Warnings and Precautions

This product is intended for oral use only, so be sure to keep it away from your eyes. If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other “caine” anesthetics, you should not use this product. Always keep it out of reach of children.

If you accidentally swallow more than the recommended amount for pain relief, seek medical help or contact a Poison Control Center immediately. 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 after 7 days, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please contact your doctor or dentist right away. Always follow the recommended dosage to avoid any complications.

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, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

It is important to know that this product is not recommended for use during pregnancy. The safety and effectiveness of this product for pregnant women have not been established, which means there is not enough information to ensure it is safe for you or your developing baby.

If you are pregnant or planning to become pregnant, it is crucial to consult with your healthcare provider before using this product. They can provide guidance tailored to your specific situation and help you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects of benzocaine on nursing infants have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety of both you and your baby.

Pediatric Use

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

For children aged 2 years and older, you can apply the medication to the affected area after drying it. You can use it up to four times a day, but not more frequently than every two hours, unless directed otherwise by a healthcare professional. Always follow the guidance of your dentist or doctor to ensure the best care for your child.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be aware of potential interactions when using 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. Discussing your complete medical history and any medications you are currently taking with your healthcare provider is essential to ensure your safety and the effectiveness of your treatment.

While there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to keep your healthcare provider informed about all medications and tests you are undergoing. This helps them provide you with the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to check the packaging before use; do not use the product if the packet is torn or open, as this could compromise its safety. Once you open the packet, remember to discard it after use to maintain hygiene and safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

This medication is applied topically and can be used up to four times a day, but not more frequently than every two hours, unless directed otherwise by your dentist or doctor.

It's important to keep this product out of reach of children. If a child accidentally swallows more than the recommended amount for pain relief, seek medical help or contact a Poison Control Center immediately. Children under 12 should be supervised while using this product, and if the user is under 2 years old, consult a dentist or doctor before use.

FAQ

What is MOUTH SORE ZEE?

MOUTH SORE ZEE is an oral pain reliever designed to temporarily relieve pain caused by various oral issues.

What conditions does MOUTH SORE ZEE relieve?

It temporarily relieves pain from toothaches, canker sores, gum sores, dental work, cheek bites, denture irritation, and minor mouth and gum injuries.

How should I use MOUTH SORE ZEE?

For adults and children 2 years and older, dry the affected area and apply the medication up to 4 times daily, but not more than every 2 hours, or as directed by a dentist or doctor.

Are there any age restrictions for using MOUTH SORE ZEE?

Children under 12 years should be supervised while using this product, and those under 2 years should consult a dentist or doctor before use.

What should I do if 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 MOUTH SORE ZEE during pregnancy?

This product is not recommended for use during pregnancy, and safety and efficacy in pregnant women have not been established.

What should nursing mothers know about MOUTH SORE ZEE?

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

What precautions should I take when using MOUTH SORE ZEE?

Avoid contact with eyes, do not use if the packet is torn or open, and keep out of reach of children.

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

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

How should I store MOUTH SORE ZEE?

Store at room temperature, protect from light, and discard after opening.

Packaging Info

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

Packaging configurations for Mouth Sore Medication.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mouth Sore Zee is an oral pain reliever indicated for the management of canker sores, gum pain, toothache, and discomfort associated with dental work. This medication is formulated to provide fast relief from mouth sores. The product is available in a net weight of 5 grams (0.017 ounces).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with various oral conditions, including toothache, canker sores, gum sores, dental work, cheek bites, denture irritation, and minor irritation or injury of the mouth and gums.

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. The medication may be used up to four times daily, with applications not exceeding every 2 hours, unless otherwise directed by a dentist or physician.

For children under 12 years of age, supervision is recommended during the use of this product to ensure safe and effective application. For children under 2 years of age, it is advised to consult a dentist or physician prior to use.

Contraindications

Use is contraindicated in patients who require treatment for longer than 7 days without the guidance of a dentist or doctor. Additionally, exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

Warnings and Precautions

Oral use only is indicated for this product. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Healthcare professionals should be aware of the allergy alert associated with this product. It should not be used in patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics.

To ensure safety, this product must be kept out of reach of children. In the event that more than the recommended amount for pain relief is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

The duration of use should not exceed 7 days unless specifically directed by a dentist or physician. If 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 for the patient to consult a healthcare provider promptly. Additionally, if any swelling, rash, or fever develops, medical attention should be sought without delay.

It is crucial to adhere to the recommended dosage and not exceed it to avoid potential adverse effects.

Side Effects

Patients should be aware that this product is intended for oral use only and should avoid contact with the eyes to prevent potential irritation or adverse effects.

In terms of allergic reactions, individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product. This precaution is critical to prevent serious allergic reactions that may occur in susceptible individuals.

It is essential for patients to discuss any known allergies with their healthcare provider prior to using this product to ensure safe and effective use.

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 potential for severe allergic reactions.

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 Mouth Sore Medication (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mouth Sore Medication.
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.

In patients aged 2 years and older, the affected area should be dried before applying the medication. It may be used up to 4 times daily, but not more frequently than every 2 hours, unless otherwise directed by a dentist or 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

This product is not recommended for use during pregnancy due to insufficient data regarding its safety and efficacy in pregnant women. The potential risks to fetal outcomes have not been established, and therefore, healthcare providers should be consulted prior to using this product in pregnant patients or those planning to become pregnant. It is essential to weigh the potential benefits against the risks when considering treatment options in this population.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. The effects of benzocaine on a nursing infant are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 product out of reach of children to prevent accidental ingestion. Instruct patients that if they accidentally swallow more than the recommended amount for pain relief, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used for more than 7 days unless directed by a dentist or doctor. They should be made aware that if symptoms of a sore mouth do not improve within 7 days, or if they experience persistent or worsening irritation, pain, or redness, or if they develop swelling, rash, or fever, they should promptly consult their doctor or dentist.

It is essential to emphasize that patients must not exceed the recommended dosage to avoid potential adverse effects.

Storage and Handling

The product is supplied in a configuration that includes individual packets. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Healthcare professionals should inspect the packets prior to use; any packet that is torn or open should not be utilized. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically and may be used up to four times daily, not exceeding every two hours, unless otherwise directed by a dentist or doctor. Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion beyond the recommended dosage for pain relief, immediate medical assistance or contact with a Poison Control Center is necessary.

For children under 12 years of age, supervision during use is recommended, and for those under 2 years, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Mouth Sore Medication, 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 Mouth Sore Medication, 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.