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Cavity Protection Fresh Mint

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Active ingredient
Sodium Fluoride 2.35 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
October 25, 2023
Active ingredient
Sodium Fluoride 2.35 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
October 25, 2023
Manufacturer
Oxyfresh Worldwide Inc
Registration number
M021
NDC root
63615-000

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Drug Overview

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this product, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

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 these issues. Regular use can be an important part of maintaining a healthy smile.

Dosage and Administration

To keep your teeth healthy, start by applying a small, pearl-sized drop of the medication onto your toothbrush. This amount is just right for effective use. After applying the medication, gently brush your teeth in a circular motion for 2 to 3 minutes.

It's important to do this after each meal to ensure the best results. By following these simple steps, you can help maintain your oral health effectively.

What to Avoid

It’s important to be aware of certain situations where you should avoid using this medication. First, do not give it to children under six years old unless a dentist or physician has specifically recommended it. Additionally, never use the product if the safety seal is torn or missing, as this could indicate that the product is not safe to use.

Be mindful that this medication may have potential for abuse or misuse, and it is classified as a controlled substance. This means it should be used only as directed by a healthcare professional to prevent any issues related to dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult with a healthcare provider if you have any questions or concerns.

Side Effects

It's important to use this product only as directed for topical application and to keep it out of reach of children. This product should not be used by children under six unless specifically recommended by a dentist or physician. If the paste is accidentally swallowed, you should contact a physician or Poison Control Center immediately.

Additionally, ensure that the safety seal is intact before use. If the seal is torn or missing, do not use the product.

Warnings and Precautions

This product is intended for topical application only, meaning it should be applied to the skin and not swallowed. It's important to keep it out of reach of children under six years old. If you have a child under this age, do not use the product unless a dentist or physician has specifically recommended it. In the event that the paste is accidentally swallowed, seek immediate help from a physician or contact a Poison Control Center.

Before using the product, ensure that the safety seal is intact. If the seal is torn or missing, do not use the product, as this may indicate that it is unsafe. Always prioritize safety and consult with a healthcare professional if you have any concerns or questions about its use.

Overdose

If you accidentally swallow the paste, it’s important to act quickly. Contact a physician or the Poison Control Center immediately for guidance. They can provide you with the necessary steps to take and help ensure your safety.

Be aware of any unusual symptoms that may arise after swallowing the paste. If you experience any concerning signs, such as difficulty breathing or extreme drowsiness, seek immediate medical attention. Your health and safety are the top priority, so don’t hesitate to reach out for help.

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 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.

Lactation Use

While there is no specific information available about the use of Cavity Protection Fresh Mint Toothpaste for nursing mothers or its effects during lactation (the period of breastfeeding), it's always a good idea to consult with your healthcare provider if you have any concerns. They can provide personalized advice based on your situation.

If you're breastfeeding, it's important to be cautious about the products you use, even those that are applied topically, like toothpaste. Always prioritize your health and your baby's well-being by discussing any new products with your doctor.

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. Always prioritize safety and consult with a healthcare professional if you have any questions about its use in young children.

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 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 change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 product's lifespan and effectiveness.

Additional Information

No further information is available.

FAQ

What is the purpose of this toothpaste?

This toothpaste helps protect against cavities.

How should I use this toothpaste?

Apply a pearl-size drop onto a toothbrush and gently brush your teeth in a circular motion for 2-3 minutes after each meal.

Who should not use this toothpaste?

Children under six should not use this toothpaste unless recommended by a dentist or physician.

What should I do if the safety seal is torn or missing?

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

What should I do if the toothpaste is accidentally swallowed?

If the paste is accidentally swallowed, contact a physician or Poison Control Center right away.

Is this toothpaste safe for children?

This toothpaste should be kept out of reach of children under six years of age and should not be used by them unless recommended by a dentist or physician.

Are there any specific drug interactions with this toothpaste?

No specific drug interactions are mentioned for this toothpaste.

Can this toothpaste be used during pregnancy or while nursing?

No specific information regarding use during pregnancy or nursing is provided in the insert.

How should I store this toothpaste?

Store the toothpaste away from direct sunlight.

Packaging Info

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

Packaging configurations for Cavity Protection Fresh Mint.
Details

Drug Information (PDF)

This file contains official product information for Cavity Protection Fresh Mint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

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

A pearl-size drop of the product should be applied onto a toothbrush. Healthcare professionals are advised to instruct patients to gently brush their teeth in a circular motion for a duration of 2-3 minutes following each meal. This method ensures effective application and optimal oral hygiene.

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

Topical application is the only approved method for use of this product; ingestion is strictly prohibited. It is imperative to keep this 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 of accidental ingestion, immediate medical attention should be sought by contacting a physician or the Poison Control Center.

Additionally, the product must not be used if the safety seal is torn or missing, as this may compromise its integrity and safety.

Side Effects

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

This product is not recommended for use in children under the age of six unless specifically advised by a dentist or physician. Additionally, it is crucial to ensure that the safety seal is intact prior to use; the product should not be used if the safety seal is torn or missing.

To ensure safety, this product should be kept out of reach of children.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Cavity Protection Fresh Mint.
Details

Pediatric Use

Pediatric patients under six years of age should not use this medication unless specifically recommended by a dentist or physician. It is important to keep this product out of reach of children in this age group to prevent accidental ingestion or misuse.

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

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 should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy or potential exposure during pregnancy with their healthcare provider.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Cavity Protection Fresh Mint Toothpaste. Therefore, the effects on breastfed infants and the excretion of the product in breast milk are not established. Lactating mothers should consult with their healthcare provider for personalized advice regarding the use of this product while breastfeeding.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of accidental ingestion of the paste, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a physician or the Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate any adverse effects. The healthcare provider will assess the situation and determine the appropriate course of action based on the specific circumstances of the overdosage.

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 that this product is not intended for use in children under the age of six unless specifically recommended by a dentist or physician. It is important for patients to understand the significance of adhering to this guideline to ensure the safety and well-being of young children.

Additionally, healthcare providers should instruct patients to seek immediate medical attention by contacting a physician or the Poison Control Center if the paste is accidentally swallowed. Emphasizing the importance of prompt action in such situations can help mitigate potential health risks.

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

No further data are available.

Drug Information (PDF)

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