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Amerfresh Toothpowder

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Active ingredient
Sodium Fluoride 0.1 g/100 g
Other brand names
Dosage form
Powder
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
March 10, 2026
Active ingredient
Sodium Fluoride 0.1 g/100 g
Other brand names
Dosage form
Powder
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
March 10, 2026
Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co. , LTD
Registration number
M021
NDC root
85162-007

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 medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this drug, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile.

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

To use this dental powder, start by wetting your toothbrush and then dip it into the powder until the bristles are fully covered. Brush your teeth and the gum line for at least 30 seconds, making sure to rinse your mouth thoroughly and spit out the mixture. It's important not to swallow any of the powder.

If you're supervising children, make sure they are capable of using the powder without help before allowing them to do so on their own. For children under 12, guide them on proper brushing and rinsing techniques to help prevent swallowing. Adults and children aged 6 and older should brush their teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or doctor advises otherwise. However, if your child is under 6 years old, do not use this product unless directed by a healthcare professional.

What to Avoid

It's important to ensure that you keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion. 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 safety guidelines to protect yourself and others.

Side Effects

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 ensure that you are using this product safely to avoid any potential risks.

Warnings and Precautions

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

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

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 can vary, 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

There is currently no specific information available regarding the use of Amerfresh Toothpowder during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including dental care items like toothpowder. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, so caution is advised. Since the effects on your nursing infant have not been thoroughly studied, be sure to keep an eye out for any unusual reactions in your baby after using the product. Your health and your baby's well-being are the top priorities, so staying informed and vigilant is key.

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 can do so safely on their own.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from moisture. It's important to keep the container tightly closed when not in use to maintain its integrity. If you open the container and do not use the contents, please discard them to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. If you are supervising children using this product, make sure to watch them closely until they can use it safely on their own. For children under 12, it's important to teach them proper brushing and rinsing techniques to help prevent swallowing the product.

FAQ

What is the primary use of this drug?

The drug aids in the prevention of dental cavities.

How should I use this drug?

Wet your toothbrush and dip it into the powder until fully covered. Brush your teeth and gum line for at least 30 seconds, then rinse and spit out thoroughly.

Can children use this drug?

Children under 6 years of age should not use this drug unless directed by a doctor or dentist. Supervise children as necessary until they can use it without supervision.

What should I do if more than the recommended amount is 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 contraindications are listed in the provided text.

Is this drug safe for nursing mothers?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

How should I store this drug?

Store at room temperature, protect from moisture, and keep the container tightly closed. Discard after opening if not used.

What precautions should I take when using this drug?

Keep out of reach of children under 6 years of age and instruct children under 12 in good brushing and rinsing habits to minimize swallowing.

Packaging Info

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

Packaging configurations for Amerfresh Toothpowder.
Details

Drug Information (PDF)

This file contains official product information for Amerfresh Toothpowder, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

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

Wet the toothbrush and dip it into the powder until the brush is fully covered. Adults and children aged 6 years and older should brush their teeth and gum line thoroughly for at least 30 seconds, preferably after each meal or at least twice a day, or as directed by a dentist or physician. After brushing, rinse the mouth and spit out the contents thoroughly. It is important not to swallow the product.

Children under 6 years of age should not use this product unless directed by a doctor or dentist. Caregivers should supervise children as necessary until they are capable of using the product without supervision. Additionally, it is recommended to instruct children under 12 years of age in proper brushing and rinsing habits to minimize the risk of swallowing.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid 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 to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

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.

The safety profile of this product emphasizes the importance of proper usage and storage to prevent accidental ingestion by young children.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Amerfresh Toothpowder.
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 regarding the use of Amerfresh Toothpowder during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed before use in this population.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; it is recommended to monitor for any adverse reactions in the infant.

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 specific guidance necessitates careful evaluation of the potential risks and benefits.

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 assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on the appropriate course of action.

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 this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from moisture. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Any unused product should be discarded after opening to ensure safety and effectiveness.

Additional Clinical Information

The route of administration for the product is topical. Clinicians should supervise children as necessary until they are capable of using the product 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 Toothpowder, 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 Toothpowder, 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.