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Zohar Anti Cavity Mouthwash Fresh Mint Flavour

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
February 27, 2024
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Liquid
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 27, 2024
Manufacturer
ZOHAR KOSHER LIMITED
Registration number
M021
NDC root
84045-003

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 dental cavities. It works by providing support to your dental health, making it easier for you to maintain a healthy smile. While specific details about how it functions are not provided, its primary purpose is to aid in cavity prevention, which is an important aspect of oral care.

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 developing cavities, which are small holes in your teeth caused by decay. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. For adults and children aged 6 years and older, measure out 10 ml (which is about 2 teaspoonfuls) of the rinse. Vigorously swish it between your teeth for 1 minute, then spit it out. It's important not to swallow the rinse. After using it, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively.

If you're supervising children under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. For children under 6 years old, it's best to consult a dentist or doctor before using the mouth rinse.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to swallow more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please use this product as directed.

Side Effects

Using this medication may lead to some side effects. If you accidentally swallow more than what is intended for rinsing, it’s important to seek medical help or contact a Poison Control Center immediately.

Always be aware of how you use the product to avoid any potential risks. If you experience any unusual symptoms or reactions, consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, 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 to ensure safety. 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 intended, especially more than what is used for rinsing, 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 considering the use of Zohar Anti-Cavity Mouthwash Fresh Mint Flavour during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the manufacturer has not provided guidance on how this mouthwash may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including mouthwash. They can help you make informed decisions based on your individual health needs and circumstances.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no detailed guidelines or warnings, it's always a good idea to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, you can use the rinse once a day after brushing their teeth. They should swish 10 ml (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. Make sure they do not swallow the rinse and avoid eating or drinking for 30 minutes after using it.

For children under 12, it's essential to teach them proper rinsing habits to reduce the risk of swallowing. Always supervise younger children until they can use the rinse safely on their own. If your child is under 6 years old, consult a dentist or doctor before use.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any medications with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any potential risks are managed effectively. Always keep an open line of communication with your doctor about any concerns or side effects you may experience.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

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 quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the bottle tightly closed when you're not using it to prevent contamination. If you open the bottle and do not use it within a specified time, be sure to discard it to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this dental rinse once a day after brushing your teeth. For adults and children aged 6 years and older, vigorously swish 10 ml (2 teaspoonfuls) of the rinse between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse and avoid eating or drinking for 30 minutes after using it. If you're supervising children under 12, make sure to guide them in good rinsing habits to prevent swallowing. For children under 6 years old, it's best to consult a dentist or doctor before use.

FAQ

What is the purpose of this mouthwash?

This mouthwash aids in the prevention of dental cavities.

How should adults and children 6 years and older use this mouthwash?

Use once a day after brushing your teeth. Vigorously swish 10 ml (2 teaspoonfuls) between your teeth for 1 minute, then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

What should I do if a child under 6 years of age needs to use this mouthwash?

Consult a dentist or doctor for guidance.

What precautions should I take when using this mouthwash?

Keep it out of reach of children. If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Are there any specific warnings associated with this mouthwash?

Yes, keep it out of reach of children and seek medical help if more than the recommended amount is swallowed.

How should I store this mouthwash?

Store at room temperature, protect from light, and keep the bottle tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Zohar Anti Cavity Mouthwash Fresh Mint Flavour (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Zohar Anti Cavity Mouthwash Fresh Mint Flavour.
Details

Drug Information (PDF)

This file contains official product information for Zohar Anti Cavity Mouthwash Fresh Mint Flavour, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

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 instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 ml (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be spat out. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing 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 importance of adhering to the recommended usage guidelines cannot be overstated, as improper use may lead to serious health consequences.

Side Effects

Patients may experience various side effects associated with the use of this product. In the event that more than the recommended amount intended for rinsing is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of adhering to the prescribed usage to mitigate potential risks.

Clinical trials and postmarketing experiences have not indicated any specific adverse reactions beyond those mentioned; however, healthcare providers should remain vigilant and monitor patients for any unexpected effects.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Zohar Anti Cavity Mouthwash Fresh Mint Flavour (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Zohar Anti Cavity Mouthwash Fresh Mint Flavour.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the recommended usage is once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 ml (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing.

Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended for these children until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is necessary 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 specific information regarding the use of Zohar Anti-Cavity Mouthwash Fresh Mint Flavour during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 available information 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 lack of data when prescribing this medication to patients with liver problems.

Overdosage

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

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination. Additionally, it is advised to discard the product after opening if it is not used within a specified time frame, although this duration is not provided in the current information.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 6 years and older, the recommended usage is once daily after brushing teeth. Patients should vigorously swish 10 ml (2 teaspoonfuls) of the rinse between their teeth for 1 minute before spitting it out. It is important not to swallow the rinse and to avoid eating or drinking for 30 minutes post-rinsing. Clinicians should instruct children under 12 years in proper rinsing techniques to minimize swallowing and supervise them as necessary until they can rinse without assistance. For children under 6 years of age, consultation with a dentist or doctor is advised.

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 Zohar Anti Cavity Mouthwash Fresh Mint Flavour, 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 Zohar Anti Cavity Mouthwash Fresh Mint Flavour, 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

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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.