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Emmi-Dent Kids

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This product has been discontinued

Active ingredient
Sodium Fluoride 110 mg/75 mL
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 110 mg/75 mL
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 3, 2024
Manufacturer
EMAG AG
Registration number
M021
NDC root
63956-002
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Emmi®-dent Ultrasound Toothpaste is a specialized toothpaste designed to help protect against cavities. This product is made in Germany and comes in a convenient 75 mL tube, making it easy to incorporate into your daily oral hygiene routine. By using this toothpaste, you can support your dental health and maintain a brighter smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to clean them thoroughly after meals or at least twice a day. If you're using this product for children aged 2 years and older, make sure they follow these guidelines or use it as directed by a dentist. Remember, you should not swallow the product.

For children under 6, use only a pea-sized amount to help minimize swallowing. It's also a good idea to supervise young children while they clean their teeth until they develop good habits. If you have a child under 2 years old, be sure to consult a dentist for advice on dental care.

What to Avoid

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is intended for dental cleaning, seek medical help or contact a Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

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 needed for dental cleaning, seek medical help or contact a Poison Control Center immediately.

Always be aware of how you use this product to ensure safety and prevent any potential issues.

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 what is typically used for dental cleaning, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed and be aware of its intended purpose. If you have any concerns or experience unusual symptoms, stop using it and consult your doctor for further guidance. 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 dental cleaning, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, so being aware of any unusual symptoms is crucial.

In case of an overdose, do not wait for symptoms to appear. Prompt action can make a significant difference in your health. Always prioritize your safety and well-being by reaching out for professional assistance right away.

Pregnancy Use

When considering the use of Emmi-Dent Kids (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 potential risks and benefits of using this product while pregnant have not been clearly established.

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

Lactation Use

If you are breastfeeding and considering using Emmi-Dent Kids (sodium fluoride paste, dentifrice), it's important to note that the drug insert does not provide specific information about its use during nursing or any potential effects on lactation. Since there are no guidelines or precautions mentioned, it may be wise to consult with your healthcare provider for personalized advice regarding the safety of this product while breastfeeding. They can help you make an informed decision based on your individual circumstances.

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 recommended amount for dental cleaning, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, you should help them clean their teeth thoroughly after meals or at least twice a day, following your dentist's instructions. To reduce the risk of swallowing, use only a pea-sized amount for children under 6.

Always supervise your child's dental cleaning until they develop good habits. If your child is under 2 years old, consult with a 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

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 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

By discussing your full medical history and any current treatments, you can help prevent potential issues and ensure that your healthcare provider can make the best decisions for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from extreme heat or cold. It's also important to protect it from light, as exposure can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these simple storage and handling 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. For adults and children aged 2 years and older, it's important to clean your teeth thoroughly after meals or at least twice a day, or follow your dentist's instructions. Remember not to swallow the medication; for children under 6, use only a pea-sized amount to help minimize swallowing. It's also essential to supervise young children during their dental cleaning until they develop good habits. If your child is under 2 years old, consult a dentist for guidance.

FAQ

What is emmi®-dent Ultrasound Toothpaste used for?

Emmi®-dent Ultrasound Toothpaste helps protect against cavities.

What is the package size of emmi®-dent Ultrasound Toothpaste?

The toothpaste comes in a 75 mL tube.

What age group can use emmi®-dent Ultrasound Toothpaste?

It is suitable for adults and children 2 years and older.

How should I use emmi®-dent Ultrasound Toothpaste?

Clean your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

Is there any risk of swallowing the toothpaste?

You should not swallow the toothpaste. To minimize swallowing, use a pea-sized amount for children under 6.

What should I do if my child accidentally swallows more toothpaste than intended?

If more than the amount used for dental cleaning is swallowed, get medical help or contact a Poison Control Center immediately.

Are there any contraindications for using emmi®-dent Ultrasound Toothpaste?

No contraindications are listed for this toothpaste.

Is emmi®-dent Ultrasound Toothpaste safe for use during pregnancy?

No specific information regarding safety during pregnancy is provided.

How should I store emmi®-dent Ultrasound Toothpaste?

Store the toothpaste at room temperature and protect it from light.

Packaging Info

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

Packaging configurations for Emmi-Dent Kids.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

KIDS emmi®-dent Ultrasound Toothpaste is a specialized dental care product designed for children. It is manufactured in Germany, ensuring adherence to high-quality standards. The formulation is tailored to support oral hygiene in young users, promoting effective cleaning through ultrasound technology.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should clean their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers are advised to supervise children's dental cleaning until proper habits are established.

For children under 2 years, it is recommended to consult a dentist for appropriate guidance on dental care.

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 exceeding that used for dental cleaning, 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 and potential harm.

In the event that more than the recommended amount used for dental cleaning is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount for dental cleaning is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this medication and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Emmi-Dent Kids.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during dental cleaning to establish good habits and to ensure that they do not swallow the product. It is recommended that a pea-sized amount be used in children under 6 to minimize swallowing. For children aged 2 years and older, dental cleaning should occur thoroughly after meals or at least twice daily, or as directed by a dentist.

In children under 2 years of age, consultation with a dentist is advised prior to use. Caregivers should keep the product out of reach of children under 6 years, and in the event of accidental ingestion of more than the recommended amount for dental cleaning, medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Emmi-Dent Kids (sodium fluoride paste, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Emmi-Dent Kids (sodium fluoride paste, dentifrice). Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants have not been established, and further research may be necessary to determine the safety and implications of use during lactation.

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 outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount used for dental cleaning, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, as these may vary based on the amount ingested and the individual's health status.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for the specific substance, ensuring that the patient receives appropriate evaluation and treatment in a timely manner.

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 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.

In the event that a patient accidentally swallows more than the recommended amount for dental cleaning, healthcare providers should instruct them to seek medical help or contact a Poison Control Center immediately. This prompt action is crucial to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from light to maintain its integrity and efficacy. Proper handling is essential to prevent exposure to conditions that may compromise the product's quality.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to clean teeth thoroughly after meals or at least twice a day, or as directed by a dentist. Patients should not swallow the product, and to minimize swallowing in children under 6 years, a pea-sized amount should be used. It is advised that clinicians supervise children's dental cleaning until good habits are established. For children under 2 years, consultation with a dentist is recommended.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Emmi-Dent Kids, 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 Emmi-Dent Kids, 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.