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Curodont Repair Fluoride Plus

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Active ingredient
Sodium Fluoride 0.02 g/100 mL
Other brand names
Dosage form
Sponge
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
June 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.02 g/100 mL
Other brand names
Dosage form
Sponge
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 2024
Label revision date
June 23, 2025
Manufacturer
CREDENTIS AG
Registration number
M021
NDC root
72247-108
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This product is an anticavity dental rinse designed to help prevent dental cavities. It works by mineralizing tooth enamel, which is the hard outer layer of your teeth, making it stronger and more resistant to decay. Additionally, it can help repair white spots on your teeth, which are early signs of tooth decay.

Using this rinse as part of your oral hygiene routine can support your dental health by providing extra protection against cavities and promoting the overall strength of your teeth.

Uses

You can use this product to help prevent dental cavities, making it a great addition to your oral care routine. It acts as an anticavity dental rinse, which means it helps to reduce the risk of tooth decay.

Additionally, this product works as an enamel mineralizer, providing essential minerals that strengthen your teeth. If you have white spots on your teeth, it can also help repair them, improving the overall appearance of your smile.

Dosage and Administration

This dental treatment rinse is designed to help prevent cavities. It contains two active components, referred to as units A and B, each at a concentration of 10 units. When using this rinse, you will need to measure out a total of 10 doses, with each dose being 0.0085 fluid ounces (which is about 0.25 milliliters).

To use the rinse effectively, simply take the prescribed amount and swish it around in your mouth as directed. Make sure to follow the instructions provided by your healthcare professional regarding how often to use it for the best results in maintaining your dental health.

What to Avoid

It's important to be aware of specific guidelines when using this medication. You should not use it at home or for any unsupervised consumer use. This ensures your safety and helps prevent any potential issues that could arise from improper use.

Currently, there are no specified contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always follow the instructions provided by your healthcare professional to ensure safe and effective use.

Side Effects

This product is intended for topical use only and should only be administered in a professional office setting. It is important to keep this product out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a poison control center immediately.

Please remember that this product is not for home or unsupervised consumer use. Always follow the guidance of a healthcare professional when using this treatment.

Warnings and Precautions

This product is intended for topical use only, meaning it should be applied to the skin and not ingested. It is designed for use in professional office settings, so please do not use it at home or without supervision from a healthcare professional.

Make sure to keep this product out of reach of children. If a child accidentally swallows more than what is typically used for rinsing, seek medical help immediately or contact a poison control center. Your safety is important, so always follow these guidelines closely.

Overdose

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, you should seek medical help or contact a poison control center immediately.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get help right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are also no dosage modifications recommended for pregnant individuals, and no special precautions have been outlined for its use in this context.

As always, it's best to consult with your healthcare provider about any medications you are considering or currently taking to ensure they are safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and provide personalized advice based on your situation.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than what is intended for rinsing, seek medical help or contact a poison control center immediately.

This product is intended for use in professional office settings only and should not be used at home or without supervision. Always ensure that children are monitored when using any products that could pose a risk to their health.

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 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 kidney function might affect the use of this medication.

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

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, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance based on your individual situation.

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 the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature in a dry, cool place. It's important to remember that this product is for single use only, so please do not attempt to reuse it.

Before using, check the safety packaging seal; if it is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How does this drug work?

It acts as an anticavity dental rinse, mineralizes enamel, and repairs white spots.

What are the instructions for using this drug?

Follow the package insert for activation and application. It is intended for professional office use only.

What should I do if I accidentally swallow more than the rinsing amount?

Get medical help or contact a poison control center immediately.

Is this drug safe for use during pregnancy?

There are no specific safety concerns or dosage modifications mentioned for pregnant individuals.

Can nursing mothers use this drug?

There are no specific statements regarding the use of this drug by nursing mothers.

What precautions should I take when using this drug?

Keep it out of reach of children and do not use it at home or for unsupervised consumer use.

How should I store this drug?

Store it at room temperature in a dry, cool place and use it only once.

Packaging Info

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

Packaging configurations for Curodont Repair Fluoride Plus.
Details

Drug Information (PDF)

This file contains official product information for Curodont Repair Fluoride Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the text.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It serves as an anticavity dental rinse and functions as an enamel mineralizer. Additionally, it is effective in repairing white spots on the enamel.

Dosage and Administration

The anticavity dental treatment rinse is formulated to contain 10 units of component A and 10 units of component B. Each dose consists of 10 individual units, with each unit measuring 0.0085 fluid ounces (0.25 milliliters).

Healthcare professionals should instruct patients to use the rinse as directed, ensuring that the full dosage is administered for optimal efficacy. The rinse should be used as part of a comprehensive oral hygiene regimen, and patients should be advised on the appropriate frequency of use based on their individual dental health needs.

Contraindications

The product is contraindicated for home use or unsupervised consumer use. This restriction is in place to ensure proper administration and monitoring by healthcare professionals, thereby minimizing potential risks associated with improper use.

Warnings and Precautions

Topical application is the sole intended route for this product, and it is strictly designated for use within professional office settings. It is imperative that this product is not utilized in home environments or for unsupervised consumer use to ensure safety and efficacy.

Healthcare professionals must ensure that this product is stored securely, out of reach of children. In the event that an amount exceeding that which is typically used for rinsing is accidentally ingested, immediate medical assistance should be sought, or contact with a poison control center is advised without delay.

Side Effects

Patients should be aware that the product is intended for topical use only and is designated for professional office use exclusively. It is crucial that this product is not used at home or for unsupervised consumer use, as improper application may lead to adverse effects.

In the event of accidental ingestion, particularly if more than the recommended amount for rinsing is swallowed, immediate medical assistance should be sought. Patients are advised to keep the product out of reach of children to prevent any potential harm. If ingestion occurs, contacting a poison control center is recommended for further guidance.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Curodont Repair Fluoride Plus.
Details

Pediatric Use

Pediatric patients should be closely monitored when using this product, as it is intended for professional office use only. It is crucial 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 should be sought, or a poison control center should be contacted. This product is not approved for home use or unsupervised consumer use in pediatric populations.

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.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate specific safety concerns. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the absence of detailed risk data when prescribing this medication to pregnant patients and weigh the potential benefits against any unknown risks. As always, it is advisable to monitor fetal outcomes and provide appropriate counseling to women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 is no information available 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.

Overdosage

In the event of overdosage, it is imperative to keep the product out of reach of children. Accidental ingestion of amounts exceeding those recommended for rinsing may pose serious health risks.

Should an individual accidentally swallow more than the prescribed amount, immediate medical assistance is necessary. Healthcare professionals are advised to contact a poison control center without delay to obtain guidance on appropriate management and treatment protocols.

Prompt action is crucial in mitigating potential adverse effects associated with 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hypersensitivity reactions, which include rash, urticaria, and angioedema.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if more than the recommended amount used for rinsing is accidentally swallowed, they should seek medical help or contact a poison control center immediately. It is important for patients to understand the potential risks associated with improper use and the necessary steps to take in case of an emergency.

Storage and Handling

The product is supplied in a single-use configuration. It must be stored at room temperature in a dry, cool place to maintain its integrity and effectiveness.

It is essential to note that the product features tamper-evident packaging. Therefore, it should not be used if the safety packaging seal is broken or missing, as this may compromise the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Curodont Repair Fluoride Plus, 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 Curodont Repair Fluoride Plus, 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.