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Amerfresh Fluoride

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Active ingredient
Sodium Fluoride 0.1 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
January 16, 2025
Active ingredient
Sodium Fluoride 0.1 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 2025
Label revision date
January 16, 2025
Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co. , LTD
Registration number
M021
NDC root
85162-002

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

Drug Overview

This medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this product, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile. It's an important tool in maintaining good dental hygiene and overall well-being.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

When using this medication, it's important not to swallow it. If you're supervising children, make sure to keep an eye on them until they can use it safely on their own. For children under 12, teach them good brushing and rinsing habits to help prevent swallowing.

For adults and children aged 6 and older, you should brush your teeth thoroughly with this product, ideally after each meal or at least twice a day, unless your dentist or doctor advises otherwise. If your child is under 6 years old, only use this medication if a doctor or dentist has specifically directed you to do so.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication as per the provided information. Always follow the guidance of your healthcare provider when using any medication.

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.

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 ensure that this product is stored safely to prevent any accidental ingestion. Your safety and the safety of your loved ones is a priority, 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 always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Your safety is the priority.

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 if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions related to lactation (the process of producing milk) or concerns about the product being present in breast milk. This means you can use the product without worrying about its effects on your milk production or your nursing infant.

Pediatric Use

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. Always supervise young children while they are using this product until they are old enough to do so on their own.

For children under 12, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing. Children aged 6 and older should brush their teeth thoroughly, ideally after each meal or at least twice a day, unless otherwise directed by a dentist or doctor. For children under 6, use this product only if a doctor or dentist has specifically recommended it.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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

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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

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 on the skin rather than taken by mouth. It is important that you do not swallow the medication. If children are using it, make sure to supervise them until they can use it safely on their own. Additionally, for children under 12, you should teach them proper brushing and rinsing habits to help prevent swallowing the product.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How should I use this drug?

Adults and children 6 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day. Children under 6 years of age should not use it unless directed by a doctor or dentist.

What precautions should I take for children?

Supervise children as necessary until they are capable of using it without supervision. Instruct children under 12 years of age in good brushing and rinsing habits to minimize swallowing.

What should I do if this drug is accidentally swallowed?

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

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

How should I store this drug?

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

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What should I know about using this drug during pregnancy?

No specific information regarding the use of this drug during pregnancy is provided.

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

What should I do if I have questions about using this drug?

Consult your doctor or dentist for any questions or concerns regarding the use of this drug.

Packaging Info

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

Packaging configurations for Amerfresh Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Amerfresh Fluoride, 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.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Patients should be instructed not to swallow the product. It is essential to supervise children as necessary until they are capable of using the product without supervision. For children under 12 years of age, caregivers should instruct them in proper brushing and rinsing habits to minimize the risk of swallowing.

For adults and children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Children under 6 years of age should not use the product unless directed by a doctor or dentist.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

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 potential risks 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 stored safely to prevent accidental ingestion by children. Proper precautions should be taken to ensure that children do not have access to the product, as this can lead to serious health risks.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Amerfresh Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a doctor or dentist. It is important to keep the product out of the reach of young children. If more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children under 12 years of age should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision of children is necessary until they are capable of using the product without assistance.

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 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

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have no specific dosage adjustments, special monitoring requirements, or precautions indicated in the available prescribing information. Therefore, the use of this medication in individuals with compromised liver function should proceed without modifications to the standard dosing regimen. It is advisable for healthcare providers to exercise clinical judgment when prescribing this medication to patients with hepatic impairment, considering the absence of specific guidance in the labeling.

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 complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for the assessment and treatment of overdosage cases, ensuring that the patient receives appropriate care based on their clinical presentation.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

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

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 not to swallow the product and to supervise children as necessary until they are capable of using it without supervision. Additionally, it is important to instruct children under 12 years of age on proper brushing and rinsing habits to minimize the risk of swallowing.

Drug Information (PDF)

This file contains official product information for Amerfresh Fluoride, 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 Amerfresh Fluoride, 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.