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Dawnmist

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This product has been discontinued

Active ingredient
Sodium Fluoride 39.9 g/181.4 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
January 23, 2012
Active ingredient
Sodium Fluoride 39.9 g/181.4 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
January 23, 2012
Manufacturer
Donavan
Registration number
part355
NDC root
55504-4341

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Drug Overview

Dawnmist anticavity fluoride toothpaste is a dental care product designed to help prevent cavities in your teeth. It contains fluoride, which is a mineral known for its ability to strengthen tooth enamel and protect against decay. By using this toothpaste regularly, you can support your oral health and maintain a brighter, 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 thoroughly after meals or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children under 6 years old, use only a pea-sized amount of toothpaste to help minimize the risk of swallowing. It's also a good idea to supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist or physician for guidance on how to care for their teeth.

What to Avoid

It's important to be aware of certain guidelines when using this product. You should not use it in children under 6 years of age. Additionally, if you accidentally swallow more than what is needed for brushing, it's crucial to seek professional help or contact a poison control center right away.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product, following these instructions will help ensure your safety and well-being.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, you should seek professional help or contact a poison control center right away.

Always use this product as directed to minimize any risks. If you have any concerns about its use, please consult with a healthcare professional.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If a child accidentally swallows more than the amount used for brushing, you should seek professional help or contact a poison control center right away.

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

Overdose

It's important to keep this medication out of reach of children under 6 years of age to prevent accidental ingestion. If you or someone else accidentally swallows more than the amount used for brushing, it's crucial to seek professional assistance right away. You can contact a poison control center for immediate guidance.

Signs of an overdose may not always be obvious, so if you suspect that an overdose has occurred, do not hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

There is currently no specific information available regarding the use of DAWNMIST - sodium fluoride paste 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 important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

It's important to establish good dental hygiene habits for your child. For children aged 2 years and older, make sure they brush their teeth thoroughly after meals or at least twice a day, following any specific instructions from your dentist or physician. If your child is under 6 years old, use only a pea-sized amount of toothpaste to reduce the risk of swallowing, and supervise their brushing until they develop good habits.

For children under 2 years, it's best to consult with a dentist or physician before using toothpaste. Always keep toothpaste out of reach of children under 6 years. If your child accidentally swallows more than the amount used for brushing, seek professional help or contact a poison control center right away.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep your doctor informed about any other medications or health conditions, as this can help ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively, which can affect how well it works for you. Your healthcare provider will likely monitor your renal function tests, which are tests that check how well your kidneys are working.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication. This helps ensure that you receive the right amount of the drug without putting extra strain on your kidneys. Always follow your healthcare provider's guidance regarding your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, always check the expiration date and batch number, which can be found on the crimp of the tube. Proper storage is essential; keep the product in a cool, dry place away from direct sunlight. When handling the product, make sure to maintain a clean environment to avoid contamination. If you have any unused portions, follow local guidelines for safe disposal to prevent any potential hazards.

Additional Information

You should use this dental product as directed by your dentist or physician. For adults and children aged 2 years and older, brush your teeth thoroughly after meals or at least twice a day. If you're supervising a child under 6 years old, use only a pea-sized amount to minimize swallowing, and ensure they are supervised while brushing until they develop good habits. For children under 2 years, consult a dentist or physician before use.

It's important to keep this product out of reach of children under 6 years. If a child accidentally swallows more than the amount used for brushing, seek professional help or contact a poison control center immediately.

FAQ

What is dawnmist anticavity fluoride toothpaste used for?

Dawnmist anticavity fluoride toothpaste aids in the prevention of dental cavities.

How should I use dawnmist anticavity fluoride toothpaste?

Adults and children 2 years and older should brush their teeth thoroughly after meals or at least twice a day. Children under 6 years should use a pea-sized amount and be supervised while brushing.

What should I do if a child under 2 years needs to use this toothpaste?

You should ask a dentist or physician before using dawnmist anticavity fluoride toothpaste for children under 2 years.

Are there any contraindications for using this toothpaste?

There are no specific contraindications listed for dawnmist anticavity fluoride toothpaste.

What should I do if I accidentally swallow more toothpaste than intended?

If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center immediately.

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

There is no specific information provided regarding the use of dawnmist anticavity fluoride toothpaste during pregnancy or lactation.

What precautions should I take for children using this toothpaste?

Keep dawnmist anticavity fluoride toothpaste out of reach of children under 6 years of age.

Are there any special considerations for patients with kidney problems?

Yes, renal impairment may require dosage adjustments, and renal function tests should be monitored in patients with kidney issues.

Where can I find the expiration date and batch number for this toothpaste?

The expiration date and batch number are located on the crimp of the tube.

Packaging Info

Below are the non-prescription pack sizes of Dawnmist (sodium fluoride). 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 anticavity fluoride toothpaste is formulated to provide effective dental care. It contains fluoride, which is known for its anticavity properties, helping to strengthen tooth enamel and prevent dental caries. The toothpaste is designed for daily use and is presented in a paste form, suitable for application with a toothbrush. Its appearance is characterized by a smooth texture and a pleasant flavor, enhancing the user experience while promoting oral hygiene.

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 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is recommended to use a pea-sized amount of the product to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

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

Contraindications

Use is contraindicated in children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional 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 to prevent accidental ingestion and potential harm.

In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, it is crucial to seek professional medical assistance or contact a poison control center immediately. Prompt action is necessary to ensure the safety and well-being of the individual involved.

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 reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional assistance or contact a poison control center immediately.

This warning highlights the importance of proper usage and supervision to prevent serious adverse reactions in young children.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Dawnmist.
Details

Pediatric Use

Pediatric patients aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician. For children under 6 years, it is recommended to use a pea-sized amount of product to minimize swallowing, and adult supervision is necessary until good brushing habits are established. For infants and children under 2 years, consultation with a dentist or physician is advised prior to use. It is important to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, professional assistance should be sought or a poison control center contacted immediately.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of DAWNMIST - sodium fluoride paste in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 overdosage, it is crucial to ensure that the product is kept out of reach of children under 6 years of age to prevent accidental ingestion.

Should an individual accidentally swallow more than the amount typically used for brushing, it is imperative to seek professional assistance or contact a poison control center immediately. Prompt action is essential to mitigate potential risks associated with overdosage. Healthcare professionals should be prepared to provide guidance on the appropriate management procedures based on the specific circumstances of the incident.

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 provided text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if they accidentally swallow more than the amount used for brushing, they should seek professional assistance or contact a poison control center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in a tube format, with the expiration date and batch number clearly indicated on the crimp of the tube.

For optimal storage and handling, it is recommended to keep the product at controlled room temperature. Specific temperature ranges have not been provided; therefore, it is advisable to avoid exposure to extreme temperatures or direct sunlight to maintain product integrity. Proper handling should be observed to prevent damage to the tube and ensure the product remains effective.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician. For children under 6 years, a pea-sized amount should be used to minimize swallowing, and brushing should be supervised until good habits are established. For children under 2 years, consultation with a dentist or physician is advised.

Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event of accidental swallowing of more than the amount used for brushing, professional assistance or contact with a poison control center should be sought immediately.

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.