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Made by Dentists Ultra Whitening Fresh Mint

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Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
March 15, 2024
Active ingredient
Sodium Fluoride 1.5 mg/1 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 2024
Label revision date
March 15, 2024
Manufacturer
MADE BY DENTISTS INC
Registration number
M021
NDC root
75065-027

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 cavities, which are small holes in your teeth caused by decay. By using this product, you can take an important step towards maintaining your dental health and keeping your smile bright.

While the specific details about how it works are not provided, its primary purpose is clear: to support you in avoiding cavities and promoting overall oral hygiene.

Uses

You can use this product to help prevent 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 dental 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. If you're helping a child under 6 years old, make sure to teach them good brushing and rinsing habits to prevent swallowing toothpaste. For these young ones, use only a pea-sized amount of toothpaste and supervise them until they can brush on their own.

If your child is under 2 years old, it's best to consult a dentist or doctor for guidance on how to care for their teeth. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of 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 immediately. This precaution helps protect their health and safety.

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 typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately. This ensures their safety and addresses any potential risks quickly.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help immediately or contact a Poison Control Center.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider for guidance.

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 immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

While the provided information does not include specific details about breastfeeding or lactation for Made by Dentists Ultra Whitening Fresh Mint toothpaste, it's important to note that there are no known risks associated with using this toothpaste while nursing. If you have any concerns about dental products and their effects on breastfeeding, it's always a good idea to consult with your healthcare provider for personalized advice. Your health and the well-being of your baby are paramount, so staying informed is key.

Pediatric Use

It's important to keep this product out of 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 immediately. 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, following the guidance of a dentist or doctor.

For children under 6, make sure to teach them proper brushing and rinsing techniques to reduce the chance of swallowing the product, and only use a pea-sized amount. Always supervise younger children while brushing until they can do it on their own safely. If your child is under 2 years old, it's best to consult with a dentist or doctor 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 avoid freezing it, as extreme cold can damage its effectiveness. When not in use, make sure to keep the tube tightly closed to maintain its integrity. Once you open the tube, remember to discard it after use to ensure safety and prevent contamination. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication is used or its effects, be sure to consult your healthcare provider.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of cavities.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. For children under 2 years, consult a dentist or doctor.

How should I use this drug?

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

What precautions should I take for children under 6 years of age?

Instruct children under 6 in good brushing and rinsing habits to minimize swallowing, and only use a pea-sized amount. Supervise them until they can use it without help.

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 right away.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

What should I do if I have questions about using this drug during pregnancy or breastfeeding?

Consult your doctor, as there is no specific information regarding use during pregnancy or breastfeeding provided.

How should I store this drug?

Store at room temperature, do not freeze, and keep the tube tightly closed when not in use. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Made by Dentists Ultra Whitening Fresh Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Made by Dentists Ultra Whitening Fresh Mint.
Details

Drug Information (PDF)

This file contains official product information for Made by Dentists Ultra Whitening Fresh Mint, 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 prevention of dental caries (cavities). It is intended for use in individuals at risk of developing cavities, including children and adults. Regular use as part of a comprehensive oral hygiene regimen is recommended to maximize its effectiveness in cavity prevention.

Dosage and Administration

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

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. A pea-sized amount of toothpaste should be used for this age group. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

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

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the potential risks associated with accidental ingestion underscores the importance of proper usage and supervision, particularly in households with young children.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning is crucial to ensure the safety and well-being of young children who may inadvertently ingest the product.

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 Made by Dentists Ultra Whitening Fresh Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Made by Dentists Ultra Whitening Fresh Mint.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

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 doctor. Caregivers should instruct children under 6 years in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is necessary until children are capable of brushing without assistance.

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

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

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Made by Dentists Ultra Whitening Fresh Mint toothpaste. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of 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 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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of 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 guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the product's quality, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The route of administration for the product is dental. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Made by Dentists Ultra Whitening Fresh Mint, 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 Made by Dentists Ultra Whitening Fresh Mint, 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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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.