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Toothpowder

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Powder
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
September 9, 2016
Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Powder
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
September 9, 2016
Manufacturer
Yangzhou Hengyuan Daily Chemical Plastic Co. , Ltd
Registration number
part356
NDC root
51289-500

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Drug Overview

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this drug, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. By incorporating it into your dental care routine, you can support your oral health and reduce the risk of developing these issues.

It's important to note that there are no reported teratogenic effects (harmful effects on fetal development) or nonteratogenic effects (harmful effects that do not affect fetal development) associated with this product, making it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between the ages of 2 and 6, make sure to use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before starting any brushing routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

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.

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, you should 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 be immediately obvious, but it’s always better to be safe and get professional advice if you think an overdose has occurred. Remember, acting quickly can make a difference in ensuring your safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware 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 have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no detailed guidelines or warnings, it’s always a good idea to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you understand any potential risks and ensure the safety of both you and your baby.

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 needed for brushing, seek medical help or contact a Poison Control Center right away. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician.

For children between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, it's best to consult with a dentist or physician before use.

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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

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 requirements or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place. It's important to keep the container tightly closed when not in use to protect the contents from moisture, which can affect their effectiveness. Once you open the container, be sure to discard any unused product, as it may no longer be safe to use after opening. Following these guidelines will help you maintain the quality and safety of the product.

Additional Information

This medication is administered through dental use. It's important to keep it out of the reach of children, especially those under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center right away.

For children aged 2 to 6 years, use only a pea-sized amount and supervise their brushing and rinsing to reduce the risk of swallowing. If your child is under 2 years old, consult a dentist or physician before use.

FAQ

What does this drug do?

This drug helps protect against cavities.

What are the instructions for adults and children 2 years and older?

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

How should I use this drug for children aged 2-6 years?

Use only a pea-sized amount and supervise the child's brushing and rinsing to minimize swallowing.

What should I do for children under 2 years?

Ask a dentist or a physician for guidance.

Are there any contraindications for this drug?

No contraindications are listed in the provided text.

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.

How should I store this drug?

Store in a cool, dry place, keep the container tightly closed when not in use, and protect from moisture.

Is this drug safe for use during pregnancy or lactation?

No specific information regarding safety during pregnancy or lactation is provided.

Are there any known drug interactions?

No specific drug interactions are mentioned.

What precautions should I take regarding children?

Keep out of reach of children under 6 years of age.

Packaging Info

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

Packaging configurations for Toothpowder.
Details

Drug Information (PDF)

This file contains official product information for Toothpowder, 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 available data.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is essential 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 contact a Poison Control Center 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 imperative 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 crucial 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.

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 Toothpowder (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toothpowder.
Details

Pediatric Use

Pediatric patients should be kept 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, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 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. In children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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. 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 and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, considering the potential risks and benefits. It is advisable to monitor breastfed infants for any adverse effects if the medication is administered to nursing mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, 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 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 compound in these areas.

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 potential risks associated with unauthorized access to the medication, highlighting the need for proper storage practices.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to keep the container tightly closed when not in use to maintain product integrity. Additionally, the product should be protected from moisture to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to keep the product out of the reach of children, particularly those 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.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount and to supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is advised before use.

Drug Information (PDF)

This file contains official product information for 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 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.

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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.