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Oral Fusion Anticavity

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.11 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
December 8, 2023
Active ingredient
Sodium Fluoride 0.11 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
December 8, 2023
Manufacturer
Yangzhou SION Commodity Co. , Ltd
Registration number
M021
NDC root
70766-010

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

You can use this medication to help protect against cavities, which are areas of decay on your teeth that can lead to more serious dental issues. It works by strengthening your teeth and making them more resistant to the bacteria that cause cavities. This can be an important part of maintaining good oral health and preventing dental problems in the future.

Uses

You can use this product to help protect against cavities. Cavities are small holes in your teeth caused by decay, and this product works to strengthen your teeth and keep them healthy. By incorporating it into your dental care routine, you can reduce your risk of developing cavities and maintain a brighter, healthier smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly after meals or at least twice a day. If you’re helping a child under 6, use only a pea-sized amount of toothpaste to minimize the chance of swallowing, and supervise them while they brush and rinse. For children under 2 years old, it's best to consult a dentist for guidance on how to care for their teeth.

Remember, do not swallow the toothpaste. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away.

Always ensure that this product is stored safely to prevent any accidental ingestion. Your safety and the safety of your loved ones is a priority.

Warnings and Precautions

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center right away.

Always use this product as directed and be cautious to prevent accidental ingestion by children. Your safety and the safety of those around you are paramount, so please take these precautions seriously.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help right away. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not be obvious, but it’s always better to be safe and get professional advice if you think you’ve taken too much. Remember, acting quickly can make a difference in your health and safety.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any concerns you may have.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any medications you are taking while breastfeeding.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. For children aged 2 years and older, you should help them brush their teeth thoroughly after meals or at least twice a day, following your dentist's instructions.

To reduce the risk of swallowing, use only a pea-sized amount for children under 6 and supervise them while they brush and rinse. If your child is under 2 years old, consult with a dentist before use. Remember, this product should not be swallowed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always keep an open line of communication with your doctor about how the medication is affecting you, especially if you notice any changes in your health or well-being.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective 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, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

The medication is applied topically, meaning it is used directly on the skin. It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center right away. To help prevent swallowing, use only a pea-sized amount for children under 6 and supervise them while they brush and rinse.

FAQ

What is the purpose of this drug?

This drug helps protect against cavities.

How should I use this drug?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What is the recommended dosage for children under 6?

For children under 6, use only a pea-sized amount and supervise their brushing and rinsing to minimize swallowing.

What should I do if a child accidentally swallows more than the recommended amount?

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

Is there any specific information for children under 2 years?

For children under 2 years, you should ask a dentist for guidance.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take regarding children?

Keep this drug out of the reach of children, especially those under 6 years of age.

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Oral Fusion Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Oral Fusion Anticavity, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the protection against dental cavities. It is intended for use in individuals seeking to maintain oral health and prevent the development of carious lesions.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed. For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing, and adult supervision is recommended during brushing and rinsing to further reduce this risk.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by minors. No other contraindications have been identified in the available data.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additionally, general precautions should be observed to ensure the safety of all users. This product should always be stored securely and kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of the reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should always be kept out of reach of children to prevent accidental ingestion and potential harm.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Oral Fusion Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Fusion Anticavity.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of children. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. A pea-sized amount should be used in children under 6 years to minimize swallowing, and adult supervision is advised during brushing and rinsing to further reduce the risk of swallowing. In children under 2 years, consultation with a dentist is advised prior to use. If more than the recommended amount is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately. It is important to instruct pediatric patients not to swallow the product.

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 consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. To reduce the risk of swallowing, it is recommended that only a pea-sized amount be used for children under 6, and that their brushing and rinsing be supervised.

Drug Information (PDF)

This file contains official product information for Oral Fusion 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 Oral Fusion 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

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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.