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Zonsen Gel Fluoride

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Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
February 11, 2025
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
February 11, 2025
Manufacturer
Wuhan Zonsen Medical Products Co. , Ltd.
Registration number
M021
NDC root
72932-015

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Drug Overview

ZONSEN is an oral care gel fluoride toothpaste designed to help you maintain good dental health. It comes in a fresh mint flavor and is packaged in a 0.6 oz. (17 g) tube. The key benefit of ZONSEN is its ability to aid in the prevention of dental cavities, making it an important part of your daily oral hygiene routine.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of tooth decay. Regular use is 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 both adults and children aged 6 years 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 keep this product out of the reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center right away.

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 ensure safe and effective use.

Side Effects

It's important to be aware of potential adverse reactions when using this product. If you accidentally swallow more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. Additionally, keep this product out of reach of children under 6 years of age to ensure their safety.

Always monitor for any unusual reactions, and if you have concerns, consult with a healthcare professional. Your safety is a priority, so don't hesitate to reach out for help if needed.

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, 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 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 the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, you should seek medical help or contact a Poison Control Center right away.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get assistance. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby.

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 what is needed for brushing, seek medical help or contact a Poison Control Center right away. Children should not swallow the product, so it's essential to supervise them until they can use it safely on their own.

For children under 12, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing. For those aged 6 and older, they should brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or doctor. Children under 6 should only use this product if a doctor or dentist specifically advises it.

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 or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 interactions with laboratory tests for the medication in question. However, always ensure that your healthcare provider is aware of all the medications you are using, as well as any tests you may undergo, to ensure your safety and the effectiveness of your treatment. This way, you can avoid any potential issues and receive the best care possible.

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 after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product for dental care by brushing your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or doctor advises otherwise. If you are using it for children under 6 years old, make sure to consult a doctor or dentist first.

It's important to keep this product out of reach of young children. If a child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center right away. Always supervise children while they brush their teeth until they can do so safely on their own, and teach children under 12 about good brushing and rinsing habits to help prevent swallowing.

FAQ

What is ZONSEN?

ZONSEN is an oral care gel fluoride toothpaste designed to aid in the prevention of dental cavities.

What flavor does ZONSEN come in?

ZONSEN is available in a fresh mint flavor.

Who can use ZONSEN?

ZONSEN is intended for adults and children 6 years of age and older. Children under 6 should not use it unless directed by a doctor or dentist.

How should I use ZONSEN?

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

What should I do if a child under 6 accidentally swallows ZONSEN?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Are there any contraindications for ZONSEN?

No contraindications are listed for ZONSEN.

Is ZONSEN safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of ZONSEN by nursing mothers.

How should ZONSEN be stored?

Store ZONSEN at room temperature and keep it out of the reach of children under 6 years of age. Discard after opening.

Packaging Info

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

Packaging configurations for Zonsen Gel Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ZONSEN (NDC: 72932-015-00) is an oral care product formulated as a gel fluoride toothpaste. It is presented in a 0.6 oz. (17 g) tube and features a fresh mint flavor. The formulation is designed to provide effective dental hygiene through the inclusion of fluoride, which aids in the prevention of dental caries.

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. This practice should be followed unless otherwise directed by a dentist or physician.

For children under 6 years of age, the product should not be used unless specifically directed by a healthcare professional.

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 more than the recommended amount for brushing, 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 prevent potential adverse effects associated with accidental ingestion.

Side Effects

Patients should be aware of the potential adverse reactions 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 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 highlights the importance of proper usage and supervision to prevent serious health risks in young children.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Zonsen Gel Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a doctor or dentist. It is essential to keep the product out of the reach of young children. Instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing.

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. Caregivers should supervise younger children during use until they are capable of using the product without assistance.

In the event that more than the recommended amount is accidentally swallowed, medical help should be sought immediately, or contact a Poison Control Center.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should 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 advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 overdosage, it is crucial to ensure that the product is kept out of the reach of children under 6 years of age. Accidental ingestion of amounts exceeding those recommended for brushing may lead to adverse effects.

Should an overdose occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center for guidance on appropriate management and intervention strategies. Prompt action is essential to mitigate potential risks associated with overdosage.

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 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 guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

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

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 6 years and older, it is recommended to brush 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, use should only occur if directed by a healthcare professional.

Clinicians should counsel patients to keep the product out of reach of children under 6 years. In the event of accidental ingestion beyond the amount used for brushing, medical assistance or contact with a Poison Control Center is advised. It is important to instruct children under 12 years in proper brushing and rinsing techniques to minimize swallowing, and supervision is recommended until they are capable of using the product without assistance.

Drug Information (PDF)

This file contains official product information for Zonsen Gel Fluoride, 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 Zonsen Gel Fluoride, 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.