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Dawnmist Fluoride Tooth

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
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
April 29, 2024
Active ingredient
Sodium Fluoride 0.1 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
April 29, 2024
Manufacturer
Yangzhou SION Commodity Co. , Ltd
Registration number
M021
NDC root
70766-015

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, which can be especially important for maintaining good oral health. By using this product, you can take an active step in reducing the risk of cavities and promoting 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 keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This routine is recommended for adults and children who are 6 years old and older. If you have any questions about your brushing habits, don’t hesitate to ask your dentist or doctor for guidance.

For children under 6 years of age, you should avoid using this product unless a doctor or dentist specifically advises you to do so. It's always best to consult with a healthcare professional to ensure the right care for younger children’s dental health.

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. 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 needed for brushing, seek medical help or contact a Poison Control Center right away.

Always use this product as directed to avoid any potential issues. If you have any concerns or experience unusual symptoms, stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of the 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. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to act quickly. Always prioritize your health and safety by reaching out for help if you’re unsure.

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 situation. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

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. For children under 12, you should supervise their use to ensure they don’t swallow the product. Teach them proper brushing and rinsing techniques to help minimize swallowing.

For children aged 6 and older, brushing should be done thoroughly, ideally after each meal or at least twice a day, unless a dentist or doctor advises otherwise. However, 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, it’s important to consult with a healthcare provider before starting the medication. 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 dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 or precautions outlined for patients like you.

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 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. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. 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 used for brushing, seek medical help or contact a Poison Control Center right away.

Make sure to supervise children while they use this product until they are capable of using it without assistance. Additionally, teach children under 12 years old proper brushing and rinsing habits to help minimize the risk of swallowing the product.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 6 years of age and older use this drug?

You should brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Can children under 6 years of age use this drug?

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

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

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

What precautions should I take regarding children and this drug?

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

Are there any known drug interactions with this drug?

No specific drug interactions are mentioned for this drug.

What are the storage instructions for this drug?

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

Is there any information regarding the use of this drug during pregnancy or lactation?

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

Packaging Info

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

Packaging configurations for Dawnmist Fluoride Tooth.
Details

Drug Information (PDF)

This file contains official product information for Dawnmist Fluoride Tooth, 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

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 a doctor.

For children under 6 years of age, the product should not be used unless directed by a doctor or dentist.

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 of accidental ingestion of an amount greater than that typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additionally, general precautions should be taken to ensure that the product remains inaccessible to children. This is crucial to prevent any potential misuse or accidental ingestion.

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 of accidental ingestion of more than the amount used for brushing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should always be stored safely to prevent access by children. Adhering to these precautions is essential to ensure the safety and well-being of pediatric patients.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Dawnmist Fluoride Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dawnmist Fluoride Tooth.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a healthcare professional. It is essential to keep the product out of reach of young children. In the event of accidental ingestion of more than the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

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

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. 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 is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 individual patient factors when prescribing to patients with reduced kidney function, as specific recommendations are not provided in the available data.

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 patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance or contact a Poison Control Center if an individual accidentally ingests more than the recommended amount used for brushing.

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

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and, if indicated, decontamination measures.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will enhance patient safety and outcomes.

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 necessity of proper storage 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 via the dental route. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, patients should seek medical assistance or contact a Poison Control Center immediately. It is important to instruct children under 12 years of age on proper brushing and rinsing techniques to minimize swallowing, and to supervise their use of the product until they are capable of using it without supervision.

Drug Information (PDF)

This file contains official product information for Dawnmist Fluoride Tooth, 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 Dawnmist Fluoride Tooth, 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.