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Anticavity

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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 2005
Label revision date
February 6, 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 2005
Label revision date
February 6, 2026
Manufacturer
Retail Business Services, LLC 
Registration number
M021
NDC root
72476-005

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Drug Overview

CARE ONE® is an anticavity mouthwash designed to help you maintain good oral health. It aids in the prevention of dental cavities, strengthens your teeth, and can even help restore enamel, which is the protective outer layer of your teeth. Additionally, it freshens your breath, making it a great addition to your daily dental care routine.

This mouthwash contains sodium fluoride and acidulated phosphate topical solution, which work together to provide these benefits. With its refreshing mint flavor, CARE ONE® offers a pleasant way to support your dental hygiene and keep your smile healthy.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which are small holes that can form in your teeth due to decay. By using this product, you can also help restore enamel, the protective outer layer of your teeth, and strengthen them overall. This means you can enjoy better oral health and a brighter smile!

Dosage and Administration

To use this mouth rinse effectively, you should follow these steps. For adults and children aged 12 and older, rinse twice a day after brushing your teeth with toothpaste. Measure out 10 mL, which is about 2 teaspoonfuls, and vigorously swish it between your teeth for one minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively. If you're supervising children under 12, make sure to teach them proper rinsing habits to avoid swallowing the rinse, and supervise them until they can rinse on their own. If your child is under 12, consult a dentist or doctor for guidance on using the rinse safely.

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 not experience any specific adverse reactions or warnings while using this medication. It's important to stay informed and monitor how you feel while taking it. If you notice anything unusual or have concerns, be sure to discuss them with your healthcare provider.

Warnings and Precautions

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

Always use this product as directed to avoid any potential issues. If you experience any unusual symptoms or reactions, stop using the product 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 important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 are no particular considerations or precautions related to lactation (the process of producing breast milk) or concerns about the product being passed into breast milk. This means you can use the product without worrying about its effects on your milk production or your nursing infant.

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 adults and children aged 12 and older, the product can be used twice daily after brushing teeth.

If your child is under 12, it's essential to teach them proper rinsing habits to reduce the chance of swallowing the product. Always supervise younger children until they can use it safely on their own. Additionally, consult a dentist or doctor before using this product for children under 12.

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, it’s important to consult with a healthcare provider for personalized advice. 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 your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function through tests is essential to ensure your safety and the effectiveness of your treatment.

For those with significant renal impairment, a lower dose of medication is recommended. Staying in close contact with your healthcare provider and following their guidance on monitoring and dosage adjustments will help manage your condition effectively.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express 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. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

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 exposure to cold weather may cause the product to temporarily appear cloudy, but this does not affect its safety or functionality.

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 are giving this medication to children under 12, make sure to teach them good rinsing habits to help minimize swallowing. It's also important to supervise younger children until they can use the medication without assistance.

FAQ

What is CARE ONE®?

CARE ONE® is an anticavity mouthwash that aids in the prevention of dental cavities, helps restore enamel, strengthens teeth, and freshens breath.

How should I use CARE ONE®?

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

What should I do if I accidentally swallow CARE ONE®?

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

Is CARE ONE® safe to use during pregnancy?

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

Can children use CARE ONE®?

Children under 12 years of age should consult a dentist or doctor before use. Instruct them in good rinsing habits and supervise as necessary.

Are there any specific warnings for CARE ONE®?

No specific warnings are listed, but it is important to keep the product out of reach of children and to seek medical help if swallowed.

What are the storage conditions for CARE ONE®?

Store CARE ONE® at a controlled room temperature of 20°C - 25°C (68°F - 77°F). Cold weather may temporarily cloud the product.

Are there any known side effects of CARE ONE®?

No specific adverse reactions or side effects are listed for CARE ONE®.

Packaging Info

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

Packaging configurations for Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Anticavity, 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 the prevention of cavities and contributes to the restoration of enamel. Additionally, this drug helps strengthen teeth, promoting overall dental health.

Dosage and Administration

Adults and children 12 years of age and older should 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 1 minute, after which the solution should be spat out. It is imperative that the rinse is not swallowed. Patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to maximize effectiveness.

For children under 12 years of age, it is advised to consult a dentist or doctor prior to use. Healthcare professionals should instruct these children in proper rinsing techniques to minimize the risk of swallowing the rinse and supervise them as necessary until they are capable of using the product independently.

Contraindications

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

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Warnings This product is intended for use as directed. It is crucial to adhere strictly to the recommended usage guidelines to avoid potential adverse effects.

General Precautions In the event that more than the recommended amount intended for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

There are no specific adverse reactions or warnings associated with the use of this product. Clinical trials and postmarketing experiences have not identified any notable adverse reactions. As such, healthcare professionals should continue to monitor patients for any unexpected effects during treatment, although no specific concerns have been documented in the available data.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity.
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 12 years and older, the product is to be used twice daily after brushing teeth with toothpaste. Children under 12 years of age should be guided in proper rinsing techniques to minimize swallowing, and supervision is recommended until they are capable of using the product without assistance. Consultation with a dentist or doctor is advised for pediatric patients under 12 years of age.

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 efficacy, 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 are no specific considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. For those with significant renal impairment, a reduced dose is recommended to mitigate potential risks associated with decreased clearance.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects 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 to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual patient's needs.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F).

In cold weather conditions, the product may temporarily cloud; however, this does not affect its quality or efficacy. Proper storage conditions must be maintained to ensure the integrity of the product.

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 the age of 12, on proper rinsing techniques to minimize swallowing, and supervision is advised until the child is capable of using the product independently.

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

Drug Information (PDF)

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