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Cavity Protection Fresh Mint Anticavity Mouthwash

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Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
September 10, 2025
Active ingredient
Sodium Fluoride 0.5 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 2014
Label revision date
September 10, 2025
Manufacturer
Oxyfresh Worldwide Inc
Registration number
M021
NDC root
63615-001

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If you are a consumer or patient please visit this version.

Drug Overview

You may be interested to know that this medication is designed to help protect against cavities, which are small holes in your teeth caused by decay. By using this product, you can support your dental health and reduce the risk of developing cavities. It's a helpful tool in maintaining a healthy smile and overall oral hygiene.

Uses

You can use this product to help protect your teeth against cavities. Cavities are small holes that can form in your teeth due to decay, often caused by bacteria. By using this product, you can support your dental health and reduce the risk of developing cavities, keeping your smile bright and healthy.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. Once it's ready, take 1 to 2 capfuls and swish it around in your mouth vigorously for at least one full minute. This helps ensure that the medication is effective.

After swishing, it's important to avoid rinsing your mouth, eating, or drinking anything for the next 5 minutes. This waiting period allows the medication to work properly without being washed away. Following these steps will help you get the most benefit from your treatment.

What to Avoid

It’s important to be cautious when using this medication. You should not give it to children under six years old unless a dentist or physician has specifically recommended it. Additionally, do not use the medication if the safety seal is torn or missing, as this could indicate that the product is not safe to use.

Always prioritize your safety and the safety of others by following these guidelines closely. If you have any questions or concerns, consult with a healthcare professional for further advice.

Side Effects

It's important to use this product only as directed. It is meant for rinsing only and should not be swallowed. Keep it out of reach of children, and do not use it for children under six unless a dentist or physician has recommended it. If more than one ounce is accidentally swallowed, you should contact a physician or Poison Control Center immediately.

Before using, ensure that the safety seal is intact; do not use the product if the seal is torn or missing.

Warnings and Precautions

It's important to use this product only for rinsing and not to swallow it. Keep it out of reach of children under six years old, and do not use it for them unless a dentist or physician has specifically recommended it. If a child accidentally swallows more than one ounce, you should contact a physician or the Poison Control Center immediately.

Before using, make sure the safety seal is intact; do not use the product if the seal is torn or missing. Following these precautions will help ensure your safety and the safety of those around you.

Overdose

If you accidentally swallow more than one ounce of the medication, it’s important to act quickly. Contact a physician or the Poison Control Center immediately for guidance.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning, don’t hesitate to seek help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Since the effects on infants who are breastfed have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to keep this medication out of reach of children under six years old. If your child is under six, do not use this medication unless a dentist or physician has specifically recommended it.

In case your child accidentally swallows more than one ounce, you should contact a physician or the Poison Control Center immediately for guidance. Always prioritize safety and consult with a healthcare professional if you have any concerns.

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 to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted 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 health needs. They can help monitor your condition and make any necessary changes to your medication regimen.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 best performance and safety of your product, store it in a cool, dry place away from direct sunlight. This helps maintain its effectiveness and prevents any potential damage.

When handling the product, be sure to follow any specific instructions provided to ensure safe use. Proper storage and careful handling are key to maximizing the benefits of your device.

Additional Information

You should take this medication orally. To use it effectively, vigorously swish 1-2 capfuls in your mouth for at least one full minute. After swishing, avoid rinsing, eating, or drinking for 5 minutes to ensure the best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the purpose of this drug?

This drug helps protect against cavities.

How should I use this product?

Shake well before using, then vigorously swish 1-2 capfuls for at least 1 full minute. Refrain from rinsing, eating, or drinking for 5 minutes afterward.

Who should not use this product?

Do not use this product if you are under six years old unless recommended by a dentist or physician.

What should I do if I accidentally swallow more than one ounce?

If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center immediately.

Is this product safe for nursing mothers?

Nursing mothers should consult a physician before using this product, as there is potential for excretion in breast milk.

What precautions should I take regarding the safety seal?

Do not use the product if the safety seal is torn or missing.

How should I store this product?

Store the product away from direct sunlight.

What should I do if I have questions about drug interactions?

No specific drug interaction information is provided, so consult your healthcare provider for any concerns.

Packaging Info

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

Packaging configurations for Cavity Protection Fresh Mint Anticavity Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Cavity Protection Fresh Mint Anticavity Mouthwash, 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 drug.

Uses and Indications

This drug is indicated for the protection against dental cavities. It is designed to support oral health by reducing the risk of cavity formation in patients.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. The recommended administration involves vigorously swishing 1 to 2 capfuls of the solution in the mouth for a minimum duration of 1 full minute. Following the swishing, patients should refrain from rinsing, eating, or drinking for at least 5 minutes to ensure optimal efficacy of the treatment.

Contraindications

Use of this product is contraindicated in children under six years of age, unless specifically recommended by a dentist or physician. Additionally, the product should not be used if the safety seal is torn or missing, as this may compromise product integrity and safety.

Warnings and Precautions

It is imperative that this product is used solely for rinsing purposes and is not intended for ingestion. Healthcare professionals should advise patients to keep the product out of reach of children under six years of age. The use of this product in children under six should only occur if specifically recommended by a dentist or physician.

In the event that more than one ounce is accidentally swallowed, immediate medical attention should be sought by contacting a physician or the Poison Control Center.

Additionally, the product should not be used if the safety seal is found to be torn or missing, as this may indicate potential contamination or compromised integrity.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for rinsing only and should not be swallowed. In the event that more than one ounce is accidentally ingested, it is imperative to contact a physician or Poison Control Center immediately.

This product is not recommended for use by children under the age of six unless specifically advised by a dentist or physician. Additionally, the product should not be used if the safety seal is torn or missing, as this may compromise its safety and efficacy.

It is essential to keep this product out of reach of children to prevent accidental ingestion and potential harm.

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 Cavity Protection Fresh Mint Anticavity Mouthwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cavity Protection Fresh Mint Anticavity Mouthwash.
Details

Pediatric Use

Pediatric patients under six years of age should not use this product unless specifically recommended by a dentist or physician. It is important to keep the product out of reach of children in this age group. In the event that more than one ounce is accidentally swallowed, immediate contact with a physician or Poison Control Center is advised.

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to 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 consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdosage, immediate medical attention is crucial. If more than one ounce of the substance is accidentally ingested, it is imperative to contact a physician or the Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for any signs of toxicity is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed as per established guidelines for the substance in question.

In summary, swift action and appropriate medical guidance are vital in managing cases of overdosage to ensure patient safety and effective treatment outcomes.

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 available in the insert.

Patient Counseling

Healthcare providers should advise patients that this product is not to be used by children under six years of age unless specifically recommended by a dentist or physician. It is important for patients to understand the age restrictions to ensure safe usage.

Additionally, healthcare providers should inform patients that in the event of accidental ingestion of more than one ounce, they should contact a physician or the Poison Control Center immediately. This precaution is crucial for ensuring patient safety and prompt medical attention if necessary.

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 away from direct sunlight to maintain its integrity and effectiveness. Proper storage conditions should be observed to ensure optimal quality.

Additional Clinical Information

The medication is administered orally, with the recommended method involving vigorous swishing of 1-2 capfuls for a minimum of one full minute. Patients should refrain from rinsing, eating, or drinking for five minutes following administration to ensure optimal effectiveness.

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

Drug Information (PDF)

This file contains official product information for Cavity Protection Fresh Mint Anticavity Mouthwash, 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 Cavity Protection Fresh Mint Anticavity Mouthwash, 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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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.