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Alcohol-Free Anticavity

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
February 6, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Liquid
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 2013
Label revision date
February 6, 2026
Manufacturer
Retail Business Services, LLC
Registration number
M021
NDC root
72476-482
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

CAREONE® is an alcohol-free fluoride mouthwash designed to help you maintain good oral health. This anticavity rinse not only aids in the prevention of dental cavities but also works to kill bad breath germs, strengthen tooth enamel, and clean your teeth. With its refreshing violet mint flavor, it provides a pleasant way to freshen your breath while supporting your overall dental hygiene.

Uses

Using this product can be beneficial for your dental health in several ways. It aids in the prevention of dental cavities, helping to keep your teeth healthy and strong. By strengthening your enamel, it provides an extra layer of protection against decay.

In addition to cavity prevention, this product also helps to kill germs that cause bad breath, ensuring your mouth stays fresh. It effectively cleans your teeth, contributing to overall oral hygiene and leaving you with a pleasant breath.

Dosage and Administration

To use this mouth rinse effectively, you should follow a few simple steps. If you are an adult or a child aged 6 years and older, use the rinse twice a day after brushing your teeth with toothpaste. Measure out 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for 1 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 are supervising a child under 12, make sure to teach them proper rinsing habits to help prevent swallowing the rinse. For children under 6 years old, it's best to consult a dentist or doctor before using this product.

What to Avoid

It's important to be cautious 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. This 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 use it as directed to avoid any potential issues.

Side Effects

You can feel reassured that there are no specific adverse reactions or warnings associated with this medication. This means that, based on current information, it is generally considered safe for use without notable side effects. However, it's always important to monitor how you feel while taking any medication and to consult your healthcare provider 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 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 is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children 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 be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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 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

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 before starting the medication. 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 your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider a reduced dose of your medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always store it in a cool, dry place. The product comes sealed with a printed neckband, which serves as a protective measure to confirm that it has not been tampered with. When handling the product, be sure to keep the area clean and avoid any contamination to maintain its integrity.

If you notice that the seal is broken or damaged, do not use the product and contact your healthcare provider for guidance. Proper storage and handling are essential for your safety and the product's performance.

Additional Information

No further information is available.

FAQ

What is CAREONE®?

CAREONE® is an alcohol-free fluoride mouthwash that acts as an anticavity fluoride rinse with a violet mint flavor.

How does CAREONE® work?

It aids in the prevention of dental cavities, kills bad breath germs, helps strengthen enamel, cleans teeth, and freshens breath.

Who can use CAREONE®?

Adults and children 6 years of age and older can use it, while children under 6 should consult a dentist or doctor.

How should I use CAREONE®?

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

What should I avoid after using CAREONE®?

Do not eat or drink for 30 minutes after rinsing to ensure maximum effectiveness.

What should I do if I accidentally swallow CAREONE®?

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

Are there any contraindications for CAREONE®?

No specific contraindications are listed for CAREONE®.

Is there any information about using CAREONE® during pregnancy or lactation?

The provided text does not include specific information regarding the use of CAREONE® during pregnancy or lactation.

What precautions should be taken for children using CAREONE®?

Instruct children under 12 in good rinsing habits to minimize swallowing and supervise them until they can use it without assistance.

What should I do if I have kidney problems?

Dosage adjustments may be necessary for patients with reduced renal function, and renal function tests should be monitored regularly.

Packaging Info

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

Packaging configurations for Alcohol-Free Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Alcohol-Free 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 cavity prevention and helps strengthen tooth enamel. Additionally, it is effective in killing bad breath germs, cleaning teeth, and freshening breath.

Limitations of Use: This product is intended for use as part of a comprehensive oral hygiene regimen and should not be used as a substitute for regular dental care.

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 expectorated. 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 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 used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance is imperative. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

It is crucial to emphasize the importance of adhering to the recommended usage guidelines to prevent potential adverse effects associated with misuse. Monitoring for any signs of distress or unusual symptoms following accidental ingestion is advised, and appropriate interventions should be initiated based on clinical judgment.

Side Effects

No specific adverse reactions or warnings have been identified in clinical trials or postmarketing experiences. As such, there are no documented adverse reactions associated with the use of this product. Patients and healthcare providers should remain vigilant and report any unexpected effects or concerns during treatment.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Alcohol-Free Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alcohol-Free 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 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 compound in these areas.

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 promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in a sealed container with a printed neckband to ensure protection. It is essential to store the product under appropriate conditions to maintain its integrity and efficacy. Specific temperature ranges and container requirements are not provided; however, it is recommended to handle the product with care to prevent any damage or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alcohol-Free 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 Alcohol-Free 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.