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Amerfresh Fluoride Gel

Last content change checked dailysee data sync status

This product has been discontinued

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 2022
Label revision date
December 16, 2024
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 2022
Label revision date
December 16, 2024
Manufacturer
Yangzhou SION Commodity Co. , Ltd
Registration number
M021
NDC root
70766-008

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 may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, making it an important part of maintaining good oral health. By using this product, you can take proactive steps to keep your smile healthy and reduce the risk of tooth decay.

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. Regular use can be an effective way to maintain a healthy smile.

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

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular conditions or risks that would prevent you from using it.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. If you have any questions or concerns, don’t hesitate to reach out to them for guidance.

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

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 or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be immediately obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

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

Given this lack of information, it is crucial 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 regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

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 the amount used for brushing, seek medical help or contact a Poison Control Center right away. Always supervise young children while they brush their teeth until they can do so safely on their own.

For children under 12, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing. For those aged 6 and older, encourage thorough brushing at least twice a day or as recommended by a dentist or doctor. Children under 6 should only use this product if directed by a healthcare professional.

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 considering this medication, it’s important to consult with a healthcare provider. 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, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those 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 health situation. They can provide guidance tailored to your needs, especially if you have concerns about your kidneys.

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. Always keep them informed about your liver health to ensure safe and effective care.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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

This medication is applied topically, meaning you will use it on the skin rather than taking it by mouth. It's important not to swallow the medication. If children are using it, make sure to supervise them until they can use it safely on their own. Additionally, if children under 12 are using it, teach them proper brushing and rinsing habits to help prevent swallowing the product.

FAQ

What is the purpose 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, or as directed by a dentist or physician.

What should I do if a child under 6 accidentally swallows this drug?

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

Are there any precautions for children using this drug?

Children under 6 years of age should not use this drug unless directed by a doctor or dentist, and they should be supervised until capable of using it without supervision.

What should I instruct children under 12 regarding this drug?

Instruct children under 12 years of age in good brushing and rinsing habits to minimize swallowing.

How should I store this drug?

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

Is there any information regarding use during pregnancy or nursing?

There is no specific information provided regarding use during pregnancy or by nursing mothers.

Are there any contraindications or risks associated with this drug?

No contraindications, abuse risks, or dependence concerns are listed for this drug.

Packaging Info

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

Packaging configurations for Amerfresh Fluoride Gel.
Details

Drug Information (PDF)

This file contains official product information for Amerfresh Fluoride Gel, 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 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 provide guidance on proper brushing and rinsing techniques 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 contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Additionally, general precautions should be observed to ensure the safety of children. This product should always be stored in a location that is inaccessible to 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 stored in a manner that prevents access by children. This precaution is essential to ensure the safety and well-being of young individuals.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Amerfresh Fluoride Gel.
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 should be sought immediately, or contact a Poison Control Center.

Children should be supervised as necessary until they are capable of using the product without supervision. For children under 12 years of age, it is advised to instruct them in proper brushing and rinsing techniques to minimize 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.

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 potential 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. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

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

Patients with hepatic impairment have not been specifically studied in clinical trials for 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. Regular monitoring of liver function may be warranted in these patients, although specific parameters are not defined in the available information.

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 adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 to ensure the safety of young individuals.

Storage and Handling

The product is supplied in configurations that include 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 maintain safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should counsel 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 Gel, 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 Gel, 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.