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Salivacaine

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This product has been discontinued

Active ingredient
Benzocaine 150 mg/3000 mg
Other brand names
Dosage form
Powder, for Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
January 17, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 150 mg/3000 mg
Other brand names
Dosage form
Powder, for Solution
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 2017
Label revision date
January 17, 2020
Manufacturer
Forward Science Technologies LLC
Registration number
part356
NDC root
70275-406
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

SalivaCAINE is an oral pain reliever designed to provide temporary relief from occasional minor oral irritation, oral pain, and sore mouth. It contains benzocaine (a local anesthetic that numbs the area) at a concentration of 5%, helping to soothe discomfort in your mouth.

This product comes in the form of a dissolving powder that you mix with water before use. Each packet contains 150 mg of benzocaine, allowing you to effectively manage minor oral pain when needed.

Uses

You can use this medication for the temporary relief of occasional minor oral irritation, oral pain, and a sore mouth. It’s designed to help soothe discomfort in these areas, making it easier for you to eat, drink, and speak comfortably.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

To use this medication, if you are an adult or a child aged 2 years and older, start by mixing the packet with 0.1 ounces of water. Once mixed, apply the rinse to the area that needs treatment. You should gargle, swish it around in your mouth, or let it sit for about one minute before spitting it out. You can use this rinse up to four times a day, or as your dentist or doctor advises.

If you are supervising a child under 12 years old, make sure to help them use the product safely. However, if your child is under 2 years of age, do not use this medication.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. You should not use it for teething, as it is not recommended for that purpose. Additionally, if you have a child under 2 years of age, do not use this medication for them, as it is not safe for young children.

There are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always follow these guidelines to ensure safe and effective use.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before. If you or a child experiences symptoms such as pale, gray, or blue skin (known as cyanosis), headache, dizziness, rapid heart rate, shortness of breath, or fatigue, it is important to stop using the product and seek immediate medical attention.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. This can happen even if you have used the product before, so it's important to be aware of the signs.

If you or a child in your care experiences any of the following symptoms, stop using the product immediately and seek emergency medical help: pale, gray, or blue skin (known as cyanosis), headache, dizziness or lightheadedness, rapid heart rate, shortness of breath, or unusual fatigue. Your health and safety are the top priority, so please take these warnings seriously.

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 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 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

When it comes to using this product during pregnancy, there is no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important 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 known 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

It's important to know that this product should not be used in children under 2 years of age. For children aged 2 years and older, you can mix the packet with 0.1 ounces of water and apply the rinse to the affected area. They should gargle, swish it around in their mouth, or let it sit for 1 minute before spitting it out. This can be done up to 4 times a day or as directed by a dentist or doctor.

If your child is under 12 years old, make sure to supervise them while they use the product to ensure they do it safely and correctly.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health safely.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it protected from light. It's important to keep the product in a tightly closed container to prevent contamination and maintain its effectiveness. After opening, remember to discard any unused product to avoid potential risks associated with using expired or compromised items. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally. For adults and children aged 2 years and older, mix the packet with 0.1 oz of water and apply the rinse to the affected area. Gargle, swish it around in your mouth, or let it sit for 1 minute before spitting it out. You can use this rinse up to 4 times a day or as directed by your dentist or doctor. If you're using it for a child under 12, make sure they are supervised during use.

FAQ

What is SalivaCAINE?

SalivaCAINE is an oral pain reliever that contains 5% Benzocaine, used for temporary relief of occasional minor oral irritation, oral pain, and sore mouth.

How do I use SalivaCAINE?

Mix one packet with 0.1 oz of water, apply the rinse to the affected area, gargle, swish around in your mouth, or allow it to remain in place for 1 minute before spitting it out. You can use it up to 4 times daily or as directed by a dentist or doctor.

Who can use SalivaCAINE?

SalivaCAINE is for adults and children 2 years of age and older. Children under 12 should be supervised while using it, and it should not be used in children under 2 years of age.

Are there any warnings associated with SalivaCAINE?

Yes, SalivaCAINE may cause methemoglobinemia, a serious condition that reduces oxygen in the blood. Seek immediate medical attention if you or a child develops symptoms like pale skin, headache, or shortness of breath.

Is there any information about using SalivaCAINE during pregnancy or while nursing?

The insert does not provide specific information regarding the use of SalivaCAINE during pregnancy or lactation, including safety concerns or recommendations.

What should I do if I experience side effects?

If you experience symptoms such as pale skin, headache, or shortness of breath, stop using SalivaCAINE and seek immediate medical attention.

How should I store SalivaCAINE?

Store SalivaCAINE at room temperature, protect it from light, and keep it in a tightly closed container. Discard any unused product after opening.

Packaging Info

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

Packaging configurations for Salivacaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SalivaCAINE is an oral pain reliever formulated with 5% benzocaine. Each packet contains 150 mg of benzocaine in a total weight of 418 mg, with a total of 12.54 g across 30 packets. The product is presented as a dissolving powder that requires mixing with water prior to use. The National Drug Code (NDC) for SalivaCAINE is 70275-0406-03.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor oral irritation, oral pain, and sore mouth.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to mix one packet of the product with 0.1 oz of water. The resulting rinse should be applied to the affected area. Patients should gargle, swish the solution around in the mouth, or allow it to remain in place for 1 minute before spitting it out. This process may be repeated up to 4 times daily or as directed by a dentist or physician. It is recommended that children under 12 years of age be supervised during the use of this product.

The product is not indicated for use in children under 2 years of age.

Contraindications

Use is contraindicated in the following situations:

  • The product should not be used for teething due to the potential for adverse effects in this context.

  • It is contraindicated in children under 2 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

The use of this product carries a significant risk of methemoglobinemia, a serious condition characterized by an abnormal level of methemoglobin in the blood, which impairs the blood's ability to carry oxygen. This adverse effect can occur even in individuals who have previously used the product without incident.

Healthcare professionals should advise patients to discontinue use and seek immediate medical attention if they or a child in their care exhibit any of the following symptoms:

  • Pale, gray, or blue-colored skin (cyanosis)

  • Headache

  • Dizziness or lightheadedness

  • Rapid heart rate

  • Shortness of breath

  • Fatigue or lack of energy

Prompt recognition and treatment of methemoglobinemia are crucial to prevent serious complications. Regular monitoring of patients using this product is recommended to ensure early detection of any adverse effects.

Side Effects

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse reaction can occur even in patients who have previously used the product without incident. It is crucial for patients and caregivers to be vigilant for symptoms indicative of methemoglobinemia, which include pale, gray, or blue-colored skin (cyanosis), headache, dizziness or lightheadedness, rapid heart rate, shortness of breath, and fatigue or lack of energy. In the event that any of these symptoms develop, immediate medical attention should be sought to ensure prompt treatment.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Salivacaine (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Salivacaine.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product. For adults and children aged 2 years and older, the recommended administration involves mixing one packet with 0.1 oz of water, applying the rinse to the affected area, gargling, swishing in the mouth, or allowing it to remain in place for 1 minute before spitting out. This can be done up to 4 times daily or as directed by a dentist or doctor. It is advised that children under 12 years of age be supervised during the use of this product to ensure safe and effective application.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning 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 available data 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 information necessitates careful clinical judgment and monitoring.

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 amount and timing of the substance taken, is crucial for effective treatment 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

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can significantly reduce the oxygen-carrying capacity of the blood and requires prompt medical intervention. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use immediately and seek urgent medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, dizziness or lightheadedness, rapid heart rate, shortness of breath, and fatigue or lack of energy.

Healthcare professionals and patients are encouraged to report any side effects experienced during the use of this product to the designated reporting number.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that this product should not be used for teething purposes. Additionally, healthcare providers must emphasize that this medication is not recommended for use in children under 2 years of age, ensuring that parents and caregivers are aware of these restrictions to promote safe usage.

Storage and Handling

The product is supplied in a tightly closed container to ensure its integrity. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. After opening, any unused product must be discarded to prevent degradation.

Additional Clinical Information

The product is administered orally. For adults and children aged 2 years and older, the recommended method involves mixing the packet with 0.1 oz of water, applying the rinse to the affected area, gargling, swishing around in the mouth, or allowing it to remain in place for 1 minute before spitting it out. This can be done up to four times daily or as directed by a dentist or doctor. It is advised that children under 12 years of age be supervised during the use of the product.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Salivacaine, 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 Salivacaine, 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.