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Sodium fluoride

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Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
October 11, 2023
Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
October 11, 2023
Manufacturer
Safco Dental Supply LLC
Registration number
M021
NDC root
67239-0227

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Drug Overview

Quantum Fresh kids FLUORIDE TOOTHPASTE is a specially formulated toothpaste designed to help protect against cavities in children. With a fun bubblegum flavor, it makes brushing more enjoyable for kids while promoting good oral hygiene. This fluoride toothpaste is manufactured by a Safco company and is suitable for daily use to support your child's dental health.

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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it safe for use during pregnancy.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 6 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children aged 2 to 6 years, use only a small amount of toothpaste—about the size of a pea. It's essential to supervise their brushing and rinsing to help prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth.

What to Avoid

It's important to keep this product out of the reach of children under 6 years of age. 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.

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 safety.

Side Effects

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 used for brushing, you should seek professional help or contact a Poison Control Center right away.

Always be aware of how to use this product safely to avoid any potential risks.

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 the amount used for brushing, you should seek professional help or contact a Poison Control Center right away.

Always use this product as directed and be cautious about the amount you use. If you have any concerns or experience unusual symptoms, 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

If you accidentally swallow more of the medication than what is typically used for brushing your teeth, it’s important to act quickly. You should seek professional assistance or contact a Poison Control Center right away.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning, don’t hesitate to get help. Remember, it’s always better to be safe and get checked out if you think you may have taken too much.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Sodium Fluoride paste, a type of toothpaste. This means that safety concerns, dosage adjustments, or any special precautions for using this product during pregnancy have not been addressed in the drug insert.

Given this lack of information, it’s advisable to consult with your healthcare provider before using Sodium Fluoride paste while pregnant. They can help you weigh the benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

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, you should seek professional help or contact a Poison Control Center right away.

For children aged 6 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician. For younger children aged 2 to 6 years, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, consult a dentist or physician 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 considering this medication, it’s important to consult with a healthcare provider. 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

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 and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they can provide the best recommendations tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the provided information. This means that the medication may not have been studied in patients with liver impairment, and there are no special monitoring or precautions outlined for you.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand any potential risks and monitor your condition effectively.

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 protected from light. It's important to note that the product has a shelf life of 2 years from the date it was packed, so be sure to check the expiration date. Once opened, please discard the product to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is used in the mouth, typically for oral health purposes. It's important to keep this product 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 professional help or contact a Poison Control Center right away.

FAQ

What is Quantum Fresh kids FLUORIDE TOOTHPASTE used for?

Quantum Fresh kids FLUORIDE TOOTHPASTE helps protect against cavities.

What is the flavor of Quantum Fresh kids FLUORIDE TOOTHPASTE?

It is bubblegum flavored.

What age group can use Quantum Fresh kids FLUORIDE TOOTHPASTE?

It is suitable for adults and children 6 years of age and older. Children 2 to 6 years should use a pea-sized amount under supervision.

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

If a child under 6 accidentally swallows more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

How should I store Quantum Fresh kids FLUORIDE TOOTHPASTE?

Store it at room temperature and protect it from light. Discard after opening.

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

There are no specific warnings or recommendations regarding use during pregnancy or lactation.

What is the expiration date for Quantum Fresh kids FLUORIDE TOOTHPASTE?

The expiration date is 2 years from the date packed.

Who manufactures Quantum Fresh kids FLUORIDE TOOTHPASTE?

It is manufactured by a Safco company.

What is the contact number for inquiries about Quantum Fresh kids FLUORIDE TOOTHPASTE?

You can contact them at 800-328-8213.

Where can I find more information about Quantum Fresh kids FLUORIDE TOOTHPASTE?

More information can be found on their website at www.QuantumLabs.com.

Packaging Info

Below are the non-prescription pack sizes of Sodium Fluoride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sodium Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Quantum Fresh Kids Fluoride Toothpaste is a bubblegum-flavored dental care product manufactured by Safco Company. The toothpaste is packaged in a net weight of 0.85 oz (24 g) and is intended for use by children. It has an expiration date of two years from the date of packing. The product is identified by the National Drug Code (NDC) 67239-0227-0 and is produced in India, with the registration number C. No. DNH/COS/DNH/52.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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, or as directed by a dentist or physician.

For children aged 2 to 6 years, a pea-sized amount of the product should be used, and caregivers must supervise the child's brushing and rinsing to minimize the risk of swallowing.

For children under 2 years of age, it is recommended to consult a dentist or physician for appropriate guidance.

Contraindications

Use is contraindicated in children under 6 years of age. Due to the risk of accidental ingestion, it is essential to keep this product out of reach of young children. In the event of accidental swallowing of more than the amount used for brushing, 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. In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, immediate professional assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should ensure that caregivers are aware of these precautions to prevent unintentional exposure and potential harm to young children.

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 the 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 crucial to seek professional assistance or contact a Poison Control Center immediately.

This precaution is essential to ensure the safety and well-being of young children, as ingestion of excessive amounts may lead to serious health concerns.

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 Sodium Fluoride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sodium Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event of accidental ingestion of more than the amount used for brushing, immediate professional assistance or contact with a Poison Control Center is advised.

For 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 physician.

For children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing.

For infants and children under 2 years of age, consultation with a dentist or physician 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 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 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 are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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, it is imperative that healthcare professionals take immediate action. If a patient accidentally ingests more than the recommended amount used for brushing, it is crucial to seek professional assistance without delay.

Healthcare providers should advise the patient or caregiver to contact a Poison Control Center immediately for guidance on the appropriate steps to take. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also important, although specific symptoms are not detailed in the provided information. Therefore, healthcare professionals should remain vigilant and prepared to manage any complications that may arise from excessive ingestion.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of the reach of children under 6 years of age. It is important to emphasize that if a child accidentally swallows more than the amount used for brushing, patients should seek professional assistance or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of young children.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. The expiration date is set for two years from the date of packing. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, patients should seek professional assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Sodium 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 Sodium 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.

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.