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Dawnmist

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Active ingredient
Sodium Fluoride 0.22 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
February 7, 2025
Active ingredient
Sodium Fluoride 0.22 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
February 7, 2025
Manufacturer
Dukal LLC
Registration number
M021
NDC root
65517-2005

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Drug Overview

DawnMist is a fluoride toothpaste designed to help you maintain good oral health by aiding in the prevention of dental cavities. It comes in a refreshing mint flavor, making your brushing experience more enjoyable. This product is manufactured by Dukal and is available in a convenient 0.6oz (17g) package.

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 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 safety and effectiveness of dental care for younger children.

What to Avoid

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

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use the product as directed to ensure your safety and well-being.

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 the amount used for brushing, seek medical help or contact a Poison Control Center right away. This precaution helps ensure their safety and well-being.

Warnings and Precautions

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 their teeth, 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 advice. 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. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Your safety is the priority.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any concerns you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

Since there are no guidelines or precautions provided, it's a good idea to consult with your healthcare provider to discuss any potential risks and to ensure the safety of both you and your infant 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 what is used for brushing, seek medical help or contact a Poison Control Center right away. Children should be supervised while using this product until they are old enough to use it 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

While there is no specific information about the use of DawnMist Fluoride Toothpaste in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting to use this toothpaste. This is especially important if you have any underlying health conditions or are taking other medications.

Remember, maintaining good oral hygiene is crucial at any age, but it’s particularly important for older adults to ensure their dental health is well-managed. If you have any questions or concerns about using this product, don’t hesitate to reach out to your dentist or doctor for personalized advice.

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 medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

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.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a 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. In this case, there are no known interactions with other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of the reach of children under 6 years of age to prevent any accidental ingestion. Once you open the product, please remember to discard it, as it should not be reused. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is DawnMist?

DawnMist is a fluoride toothpaste that aids in the prevention of dental cavities.

What is the recommended usage for adults and children over 6?

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 doctor.

Can children under 6 use DawnMist?

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

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 using DawnMist?

No specific contraindications are mentioned for DawnMist.

Is there any information about using DawnMist during pregnancy or lactation?

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

How should DawnMist be stored?

DawnMist should be stored at room temperature and kept out of the reach of children under 6 years of age.

What flavor does DawnMist have?

DawnMist has a fresh mint flavor.

Packaging Info

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

Packaging configurations for Dawnmist.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DawnMist is a fluoride toothpaste formulated to promote oral health. It is presented in a 0.6 oz (17 g) tube and features a fresh mint flavor. The product is manufactured by Dukal and is identified by the National Drug Code (NDC) 65517-2005-0.

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

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount for brushing is swallowed, seek medical assistance or contact a Poison Control Center immediately.

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 with a Poison Control Center is advised. This precaution is essential to ensure the safety and well-being of young children who may be at risk of adverse effects from improper use.

Side Effects

Patients should be advised 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 swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of accidental ingestion in young children and underscores the importance of proper usage and storage of the product.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not have clinically significant interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Dawnmist.
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.

For 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 doctor. Children under 12 years of age should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is advised until children are capable of using the product without assistance.

Geriatric Use

Elderly patients may use DawnMist Fluoride Toothpaste; however, the prescribing information does not provide specific guidance regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise clinical judgment when recommending this product to geriatric patients, considering individual health status and potential sensitivities. Monitoring for any adverse effects or unusual reactions may be prudent, given the lack of specific data for elderly individuals.

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 are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of pregnancy-related data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any 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 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 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 readily 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 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 the product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of the reach of children under 6 years of age to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dawnmist, 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, 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.