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Oral Antivavity

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Active ingredient
Sodium Fluoride 10.41 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
February 27, 2026
Active ingredient
Sodium Fluoride 10.41 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 2015
Label revision date
February 27, 2026
Manufacturer
The Kroger Co.
Registration number
M021
NDC root
30142-576

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Drug Overview

FLUORIDE is an anticavity mouthwash designed to help you maintain good oral health. It aids in the prevention of dental cavities by strengthening your tooth enamel, which is the protective outer layer of your teeth. In addition to cavity prevention, this mouthwash cleans your teeth, freshens your breath, and helps eliminate bad breath germs.

This alcohol-free mouthwash is a convenient option for daily use, ensuring that you can take care of your dental hygiene without the harsh effects of alcohol. By incorporating FLUORIDE into your routine, you can support your efforts to keep your smile healthy and bright.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which means it helps stop those pesky holes from forming in your teeth. Additionally, it cleans your teeth and freshens your breath, making your mouth feel clean and pleasant.

This product also works to strengthen your enamel, the protective outer layer of your teeth, ensuring they stay strong against decay. Plus, it effectively kills the germs that cause bad breath, helping you maintain a fresh smile throughout the day.

Dosage and Administration

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

If you're helping a child under 12, 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 use this product safely. If you accidentally swallow more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center. This precaution ensures your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always follow the usage instructions carefully to avoid any potential issues.

Side Effects

You can feel reassured that there are no adverse reactions or warnings associated with this medication based on the information provided. This means that, as of now, there are no known serious side effects to be concerned about. Always consult with your healthcare provider if you have any questions or experience any unusual symptoms while taking this medication.

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 unusual 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, contact your local emergency services or go to the nearest hospital. 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

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that the information available does not provide clear recommendations or warnings for pregnant individuals. If you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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, the recommended use is twice a day after brushing their teeth. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute and then spit it out.

For children under 12, it's essential to teach them proper rinsing habits to reduce the risk of swallowing the rinse. Always supervise younger children until they can use the product safely on their own. If your child is under 6 years old, please 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 wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always ensure that your doctor is aware of all medications being taken, as this can help avoid any unexpected interactions or side effects.

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 care and consideration are necessary to ensure your treatment is safe and effective. Always discuss your kidney health with your healthcare provider to determine the best approach for your medication management.

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 detailed guidelines available regarding how the medication may affect you or how your liver health might influence the treatment.

Before starting any new medication, it's essential to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that your liver health is taken into account. Always keep your doctor informed about any changes in your health or any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the bottle tightly closed when you're not using it to prevent contamination. Once opened, please remember to discard the product, as it should not be reused. Following these guidelines will help maintain the product's effectiveness and safety for your use.

Additional Information

You should take this medication orally, twice a day, after brushing your teeth with toothpaste. If you have children under 12, it's important to teach them good rinsing habits to help prevent swallowing the medication. Make sure 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 before use.

FAQ

What is FLUORIDE used for?

FLUORIDE is an anticavity mouthwash that aids in the prevention of dental cavities, cleans teeth, freshens breath, and helps strengthen enamel.

How should I use FLUORIDE mouthwash?

Use FLUORIDE mouthwash twice a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute, then spit it out.

Can children use FLUORIDE mouthwash?

Children under 6 years of age should consult a dentist or doctor. For children under 12, instruct them in good rinsing habits and supervise their use.

What should I do if I accidentally swallow FLUORIDE mouthwash?

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Are there any contraindications for using FLUORIDE?

No contraindications are listed for FLUORIDE in the provided information.

How should I store FLUORIDE mouthwash?

Store FLUORIDE at room temperature, protect it from light, and keep the bottle tightly closed when not in use.

Is FLUORIDE safe to use during pregnancy or while nursing?

The provided information does not mention any specific warnings or recommendations regarding the use of FLUORIDE during pregnancy or nursing.

What are the potential side effects of FLUORIDE?

No adverse reactions or side effects are listed in the provided information for FLUORIDE.

Packaging Info

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

Packaging configurations for Oral Antivavity.
Details

Drug Information (PDF)

This file contains official product information for Oral Antivavity, 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 cavity prevention, cleans teeth, freshens breath, strengthens enamel, and kills germs that cause bad breath.

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

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with 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.

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 demonstrates the ability to use the rinse independently.

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

Contraindications

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

Warnings and Precautions

For this product, it is imperative to exercise caution to ensure safe usage. In the event that more than the recommended amount intended for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to manage potential complications arising from ingestion.

It is essential to monitor patients for any adverse reactions following the use of this product, particularly in cases of accidental ingestion. Prompt intervention can mitigate risks and ensure patient safety.

Side Effects

There are no adverse reactions or warnings associated with the use of this product as per the available data. Clinical trials and postmarketing experiences have not reported any adverse reactions. Therefore, healthcare professionals and patients can consider this information when evaluating the 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 Oral Antivavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Antivavity.
Details

Pediatric Use

Pediatric patients should be instructed to keep this 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 recommended usage is twice daily after brushing teeth with toothpaste. They should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute before spitting it out. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing the rinse. 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is recommended that healthcare providers remain vigilant and informed about any new data that may emerge regarding the use of this medication in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in patients with reduced kidney function. Dosage adjustments should be guided by creatinine clearance levels to ensure safe and effective use of the medication. Special consideration is warranted for patients with severe renal impairment, as they may require more careful management to avoid potential adverse effects.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the clinical presentation.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation.

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 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 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 a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of twice a day following brushing with toothpaste. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing. It is advised that children be supervised during use until they 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 Oral Antivavity, 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 Oral Antivavity, 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.