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Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2024
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M021
NDC root
69968-0687

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Drug Overview

LISTERINE® SMART RiNSE is an anticavity fluoride rinse that contains sodium fluoride and acidulated phosphate. This mouthwash is designed to help prevent dental cavities, making your teeth stronger and providing better cavity protection when used alongside regular brushing.

This alcohol-free rinse comes in a refreshing Berry Splash flavor and is available in a 500 mL (16.9 Fl Oz) bottle. By incorporating LISTERINE® SMART RiNSE into your oral hygiene routine, you can support your dental health effectively.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After brushing your teeth with toothpaste, you should use the mouth rinse twice a day. To do this, take 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for one minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively.

If you're helping a child under 12 years old, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise them until they can use it on their own. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care when using it.

If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. This precaution helps ensure safety and prevent any potential harm.

Warnings and Precautions

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for advice. Your safety is a priority, so don’t hesitate to reach out for help if you have any concerns.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

There is currently no specific information available about the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including mouth rinses, to ensure they are safe for you and your baby.

Lactation Use

There is no specific information available about the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH for nursing mothers or its effects during lactation (the period of breastfeeding). If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider before using any new products, including mouth rinses, to ensure they are safe for you and your baby.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, you can use this product twice a day after brushing their teeth with toothpaste.

For children under 12, make sure to teach them proper rinsing habits to help prevent swallowing. Always supervise younger children until they can use the product safely on their own. If your child is under 6 years old, it's best to consult with a dentist or doctor before use.

Geriatric Use

While there is no specific information about the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before using this mouth rinse, especially if you have any underlying health conditions or are taking other medications.

As you or your loved ones age, changes in health can affect how products work in the body. Therefore, it’s important to ensure that any oral care product fits well with your overall health plan. Always prioritize safety and seek guidance if you have any questions or concerns.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring 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 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 you may have 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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. If you notice any cloudiness during cold weather, don’t worry; this is a temporary condition and should resolve once the product returns to a warmer environment. Always handle the product with care to avoid any damage.

Additional Information

You should take this medication orally, using it twice a day after brushing your teeth. To use the rinse, vigorously swish 10 mL (which is about 2 teaspoonfuls) between your teeth for 1 minute, then spit it out. It's important not to swallow the rinse and to avoid eating or drinking for 30 minutes after using it.

If you have children under 12, make sure to teach them good rinsing habits to prevent swallowing the rinse. Supervise younger children until they can use it safely on their own. For children under 6 years old, consult a dentist or doctor before use.

FAQ

What is LISTERINE® SMART RiNSE?

LISTERINE® SMART RiNSE is an anticavity fluoride rinse that contains sodium fluoride and acidulated phosphate, designed to aid in the prevention of dental cavities.

How should I use LISTERINE® SMART RiNSE?

You should use LISTERINE® SMART RiNSE twice a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) of the rinse between your teeth for 1 minute and then spit it out.

Can children use LISTERINE® SMART RiNSE?

Yes, children 6 years of age and older can use it, but they should be instructed in good rinsing habits to minimize swallowing. Children under 6 years should consult a dentist or doctor.

What should I do if I accidentally swallow LISTERINE® SMART RiNSE?

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

Is LISTERINE® SMART RiNSE safe for pregnant or nursing women?

The drug insert does not provide specific information regarding the use of LISTERINE® SMART RiNSE during pregnancy or lactation, so consult your healthcare provider.

Are there any contraindications for using LISTERINE® SMART RiNSE?

No specific contraindications are listed for LISTERINE® SMART RiNSE.

What precautions should I take when using LISTERINE® SMART RiNSE?

Keep LISTERINE® SMART RiNSE out of reach of children and do not eat or drink for 30 minutes after rinsing.

What flavor does LISTERINE® SMART RiNSE come in?

LISTERINE® SMART RiNSE is available in a Berry Splash flavor.

How should I store LISTERINE® SMART RiNSE?

Store LISTERINE® SMART RiNSE at room temperature. Cold weather may temporarily cloud the product.

Packaging Info

Below are the non-prescription pack sizes of Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash.
Details

Drug Information (PDF)

This file contains official product information for Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

LISTERINE® SMART RiNSE® is a sodium fluoride and acidulated phosphate topical solution formulated to enhance oral health. This alcohol-free solution is presented in a 500 mL (16.9 Fl Oz) volume and features a Berry Splash flavor. The formulation is designed to provide twice the strength for teeth, contributing to improved cavity protection when used in conjunction with regular brushing, as demonstrated in laboratory studies.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the product independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no contraindications listed for this product. However, it is important to note that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, the product is indicated for use twice daily following tooth brushing with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of the patient's overall health status.

Pregnancy

There is no specific information regarding the use of LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for LISTERINE SMART RINSE ANTICAVITY FLUORIDE RINSE - BERRY SPLASH. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants have not been established, and further research may be necessary to determine the safety of this product during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and addressing potential risks associated with misuse.

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 to maintain its integrity and effectiveness. In colder weather conditions, the product may temporarily cloud; however, this does not affect its quality. Proper handling should ensure that the product is kept within the recommended temperature range to avoid any adverse effects.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily following tooth brushing. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes after use.

Clinicians should counsel patients, particularly parents of children under 12 years of age, to instruct their children in proper rinsing techniques to minimize the risk of swallowing. Supervision is advised for children until they are capable of rinsing without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash, 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 Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash, 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.