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Dawnmist Gel 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
70766-014

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 support to your dental health, making it easier for you to maintain a healthy smile. While specific details about its mechanism of action are not provided, its primary purpose is to aid in cavity prevention, which is an important aspect of oral care.

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

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 who are 6 years old and older. If you have any questions about how to brush or how often, don’t hesitate to ask your dentist or doctor for guidance.

For children under 2 years of age, it's best to consult with a doctor or dentist before starting any brushing routine. They can provide specific recommendations tailored to your child's needs.

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. Your safety and the safety of others 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 and be cautious to prevent any accidental ingestion. If you have any concerns or experience unusual symptoms, stop using the product 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. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not always be obvious, so it's crucial to act quickly. If you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, your health and safety are the top priority.

Pregnancy Use

When considering the use of DAWNMIST GEL FLUORIDE TOOTH (sodium fluoride paste, dentifrice) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been clearly studied or established.

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

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 are old enough to do it safely on their own.

For children under 12, make sure 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 directed otherwise by a dentist or doctor. If your child is under 2 years old, it's best to consult with a doctor or dentist 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, 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

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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 with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

Remember, even if no interactions are listed, your health is unique, and discussing your full medical history is essential for safe and effective treatment.

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 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 purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 6 years and older use this product?

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

What should I do if my child is under 2 years of age?

Consult a doctor or dentist before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take regarding children?

Keep this product out of the reach of children under 6 years of age. If swallowed in excess, seek medical help or contact a Poison Control Center immediately.

Is there any information about using this drug during pregnancy?

There is no specific information regarding the use of this product during pregnancy.

What should nursing mothers know about this product?

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

How should I store this product?

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

What should I do if my child cannot use this product without supervision?

Do not swallow; supervise children as necessary until they are capable of using it without supervision.

Packaging Info

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

Packaging configurations for Dawnmist Gel Fluoride Tooth.
Details

Drug Information (PDF)

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

Adults and children 6 years of age and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day. This should be done or as directed by a dentist or a doctor to ensure optimal oral hygiene.

For children under 2 years of age, it is recommended to consult a doctor or dentist prior to use to determine appropriate dental care practices.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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 typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Additionally, it is important to ensure that the product remains out of reach of all children to prevent any unintended exposure or ingestion.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Dawnmist Gel Fluoride Tooth.
Details

Pediatric Use

Pediatric patients should be supervised during the use of this product, particularly those under 6 years of age, to prevent accidental ingestion. It is advised to keep the product out of the reach of children in this age group. For children under 12 years, proper instruction in brushing and rinsing techniques is essential to minimize the risk of swallowing.

For effective use, adults and children aged 6 years and older are recommended to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a healthcare professional. Children under 2 years of age should consult a doctor or dentist prior to use. In the event of accidental ingestion of more than the recommended amount, immediate medical assistance or contact with a Poison Control Center is necessary.

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 DAWNMIST GEL FLUORIDE TOOTH (sodium fluoride paste, dentifrice) during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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 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 warranted based on clinical judgment.

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 situations. Symptoms 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 for patients to understand the potential risks associated with improper access to the medication by 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 Gel 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 Gel 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.