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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
January 9, 2025
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
January 9, 2025
Manufacturer
Safco Dental Supply LLC
Registration number
M021
NDC root
67239-0226

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Drug Overview

Quantum Fresh Fluoride Toothpaste is designed to help protect your teeth against cavities. It contains fluoride, a mineral that strengthens tooth enamel and makes it more resistant to decay. Using this toothpaste regularly can contribute to better oral health by reducing the risk of cavities and promoting a brighter smile.

Uses

This medication is designed to help protect you against cavities, which are areas of decay on your teeth that can lead to more serious dental issues if not treated. By using this product, you can take an important step in maintaining your oral health and preventing tooth decay.

It's important to note that this medication does not have any known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for those concerned about potential risks while using it.

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 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 what is typically used for brushing, please seek professional help or contact a Poison Control Center right away.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of 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 the potential risks associated with any medication or product, and ensure that it is used safely and appropriately.

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 needed 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 used. If you experience any unusual symptoms or reactions, 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 advice from a healthcare professional.

Pregnancy Use

When it comes to using Sodium Fluoride paste (a type of toothpaste) during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the drug insert does not provide guidance on whether it is safe to use while you are pregnant.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including dental care items like fluoride paste. They can help you make informed decisions based on your individual health needs.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

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 the amount used 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, it's best to consult with 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

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and protect it from light. Be mindful of the expiration date, which is two years from the date it was packed. Once opened, please discard the product to maintain safety and effectiveness.

It's important to keep the product out of the reach of children under 6 years of age to prevent any accidental ingestion. 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 Fluoride Toothpaste used for?

Quantum Fresh Fluoride Toothpaste helps protect against cavities.

What should adults and children 6 years and older do when using this toothpaste?

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

How should children aged 2 to 6 use this toothpaste?

Children aged 2 to 6 should use only a pea-sized amount and should be supervised while brushing and rinsing to minimize swallowing.

What should I do if a child under 6 accidentally swallows more toothpaste than used for brushing?

Seek professional assistance or contact a Poison Control Center immediately.

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

No specific information regarding use during pregnancy or lactation is provided.

How should I store Quantum Fresh Fluoride Toothpaste?

Store at room temperature, protect from light, and keep out of the reach of children under 6 years of age.

What is the expiration date for this toothpaste?

The expiration date is 2 years from the date packed.

Are there any contraindications for using this toothpaste?

No contraindications are listed for Quantum Fresh Fluoride Toothpaste.

What is the contact information for the manufacturer?

The manufacturer, Safco Company, can be contacted at 800-328-8213 or through 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 Fluoride Toothpaste is a dental care product designed to promote oral health. It is packaged in a net weight of 0.85 oz (24 g) and is identified by NDC 67239-0226-0. The product has a shelf life of 2 years from the date of packing. Quantum Fresh Fluoride Toothpaste is manufactured in India.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, 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, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

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

Contraindications

Use is contraindicated in children under 6 years of age. Accidental ingestion of amounts greater than those used for brushing requires immediate professional assistance or contact with a Poison Control Center.

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 the individual should contact a Poison Control Center without delay.

Healthcare professionals are advised to educate caregivers on the importance of proper storage and usage to prevent accidental ingestion. Monitoring for any signs of adverse reactions or complications following misuse is also recommended.

Side Effects

Patients should be aware of the serious warning associated with 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 who may be at risk of adverse effects from improper use.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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 recommended amount 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

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 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 available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 crucial to ensure the safety and well-being of young children.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at room temperature, away from direct light to maintain its efficacy. The expiration date is set at two years from the date of packing, and it is essential to discard the product after opening to ensure safety and effectiveness.

Additionally, it is crucial to keep the product out of the reach of children under six years of age to prevent accidental ingestion. Proper handling and storage conditions are vital for maintaining the quality of the product throughout its shelf life.

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

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.