ADD CONDITION

items per page

Mouth Rinse

Last content change checked dailysee data sync status

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 2006
Label revision date
February 12, 2026
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 2006
Label revision date
February 12, 2026
Manufacturer
Walgreen Co.
Registration number
M021
NDC root
0363-0163

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

Sodium Fluoride & Acidulated Phosphate Topical Solution is an anticavity rinse designed to help you maintain good oral health. It works by preventing dental cavities, strengthening your teeth, and restoring enamel, which is the protective layer on your teeth. Additionally, this solution helps kill germs that cause bad breath and freshens your breath, making it a great addition to your daily dental care routine.

This rinse is available in a refreshing eucalyptus mint flavor and is recommended by Walgreens pharmacists. With a volume of 33.8 fl oz (1 L), it provides a convenient way to support your dental hygiene efforts and keep your smile healthy.

Uses

Using this product can be beneficial for your dental health in several ways. It helps prevent dental cavities, which are small holes in your teeth caused by decay. By using it regularly, you can strengthen your teeth, making them more resistant to damage.

Additionally, this product is effective in killing germs that cause bad breath, helping you maintain fresh breath throughout the day. Incorporating it into your oral care routine can lead to healthier teeth and a more confident smile.

Dosage and Administration

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, rinse twice a day after brushing your teeth with toothpaste. 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 the mouth rinse, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively. If you're supervising children under 12, make sure to guide them on how to rinse properly to prevent swallowing. 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

You may experience some adverse reactions while using this product. It's important to be aware of potential side effects, which can vary in severity. If you notice any unusual symptoms, it's best to consult with your healthcare provider.

Please keep in mind that there are specific warnings associated with this product. Make sure to discuss these with your doctor to ensure you understand any risks involved. Your health and safety are the top priority, so don't hesitate to reach out if you have any concerns.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. If you accidentally swallow more than what is intended for rinsing, seek emergency medical help immediately or contact a Poison Control Center.

Additionally, always follow the recommended usage instructions to avoid any potential risks. If you experience any unusual symptoms or reactions while using this product, stop use and call your doctor for further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of sodium fluoride mouthwash during pregnancy has not been established. There may be potential risks to your fetus, and further studies are needed to fully understand these risks. Therefore, it is crucial to consult with your healthcare provider before using this mouthwash.

If your healthcare provider determines that you can use sodium fluoride mouthwash, it should only be used if clearly needed. There are no specific dosage modifications for pregnant individuals, but always prioritize open communication with your healthcare professional regarding any concerns or questions you may have.

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 it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is needed 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 daily after brushing their teeth with toothpaste.

For children under 12, make sure to teach them good 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 a dentist or doctor before use.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for determining the appropriate use of this medication based on individual health needs. Always ensure that any treatment plan is tailored to your specific situation.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your renal function (how well your kidneys are working) is reduced. Regular monitoring of your renal function is essential, as dosage adjustments are based on your creatinine clearance levels (a measure of how well your kidneys filter waste).

For those with severe renal impairment, special considerations are necessary to ensure your safety and the effectiveness of your treatment. Always consult with your healthcare provider to determine the best approach for your specific situation.

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 or tests you may be taking. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions and share any concerns you may have regarding your medications.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain its effectiveness. Be aware that if the product is exposed to cold weather, it may temporarily become cloudy, but this does not affect its safety or function.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally, twice a day, after brushing your teeth with toothpaste. If you have children under 12, make sure to teach them good rinsing habits to help prevent swallowing the medication. It's important to supervise younger children until they can use it safely on their own. If your child is under 6 years old, consult a dentist or doctor for guidance.

FAQ

What is Sodium Fluoride & Acidulated Phosphate Topical Solution used for?

It is an anticavity rinse that aids in the prevention of dental cavities, strengthens teeth, and freshens breath.

How should I use this mouthwash?

Use twice daily after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute and then spit it out. Do not swallow the rinse.

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

Get medical help or contact a Poison Control Center right away.

Is this product safe for children?

Children under 6 years of age should consult a dentist or doctor. For children under 12, supervise them to ensure they use it properly without swallowing.

Can I use this mouthwash during pregnancy?

The safety of this mouthwash during pregnancy has not been established. Consult a healthcare provider before use if you are pregnant or planning to become pregnant.

What are the storage conditions for this product?

Store at a controlled room temperature of 20⁰ - 25⁰C (68⁰ - 77⁰ F).

Are there any contraindications for using this mouthwash?

There are no specific contraindications listed, but consult a healthcare provider if you are pregnant or have renal impairment.

Packaging Info

Below are the non-prescription pack sizes of Mouth Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mouth Rinse.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in strengthening teeth and helps to prevent the formation of cavities. Additionally, this drug is effective in killing germs that cause bad breath.

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 rinse should be spat out. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure 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 rinse independently and safely.

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

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

It is imperative to adhere strictly to the recommended usage guidelines to mitigate the risk of adverse effects associated with this product. Regular monitoring of patients is essential to ensure safe and effective use, particularly in cases where the product may be misused or ingested inappropriately.

Side Effects

Patients receiving this product may experience adverse reactions. Serious adverse reactions have been reported, necessitating careful monitoring and management.

In clinical trials, participants exhibited a range of adverse reactions, with some requiring intervention. Postmarketing experiences have also revealed additional adverse reactions that were not fully characterized during clinical trials.

Healthcare professionals should remain vigilant for these adverse reactions and consider them when evaluating the overall safety profile of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mouth Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mouth Rinse.
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, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the product is to be used 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 necessary prior to use.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of sodium fluoride mouthwash during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. There may be potential risks to the fetus, and further studies are needed to determine the safety of sodium fluoride mouthwash in this population. No specific dosage modifications are provided for pregnant individuals. It is recommended that sodium fluoride mouthwash be used only if clearly needed and after a thorough discussion with a healthcare professional.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Special considerations are warranted for patients with severe renal impairment to mitigate potential risks associated with treatment.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients and caregivers about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 provided in the insert.

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 rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act swiftly in such situations to ensure their safety.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature ranging from 20°C to 25°C (68°F to 77°F).

In colder weather conditions, the product may temporarily cloud; however, this does not affect its efficacy. Proper storage conditions should be maintained to ensure the integrity and quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of twice daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing, and supervision is advised until children are capable of using the product independently. For children under 6 years of age, consultation with a dentist or doctor is recommended.

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

Drug Information (PDF)

This file contains official product information for Mouth Rinse, 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 Rinse, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.