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Sodium Fluoride

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Active ingredient
Sodium Fluoride 220 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
June 27, 2024
Active ingredient
Sodium Fluoride 220 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
June 27, 2024
Manufacturer
Dynarex Corporation
Registration number
M021
NDC root
67777-180

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Drug Overview

5900 Clear Mint is a gel toothpaste designed to help protect your teeth against cavities. By using this toothpaste regularly, you can support your dental health and maintain a brighter smile. Its mint flavor also provides a refreshing taste, making your oral care routine more enjoyable.

Uses

You can use this product to help protect your teeth against cavities. It works by strengthening your enamel and creating a barrier that helps prevent decay. This is especially important for maintaining good oral health and keeping your smile bright.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe choice for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child under 6, use only a pea-sized amount of toothpaste to reduce the risk of swallowing, and make sure to supervise their brushing and rinsing until they develop good habits.

For children under 2 years old, it's best to consult with a dentist or physician before using any toothpaste. This way, you can ensure that you're taking the right steps for your child's dental health.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

If you accidentally swallow more than the amount used for brushing, it’s important to seek medical help or contact a Poison Control Center (1-800-222-1222) right away. Additionally, please ensure that this product is kept out of reach of children under 6 years of age to prevent any accidental ingestion.

Warnings and Precautions

If you accidentally swallow more than the amount used for brushing, it’s important to seek medical help right away or contact a Poison Control Center at 1-800-222-1222. This is crucial to ensure your safety and well-being.

To keep children safe, make sure to keep this product out of reach of children under 6 years of age. Always supervise young children when they are using any dental products to prevent accidental swallowing.

Overdose

If you accidentally swallow more than the amount used for brushing your teeth, it’s important to seek medical help right away. You can contact a Poison Control Center at 1-800-222-1222 for immediate assistance.

Signs of an overdose may not always be obvious, so it's crucial to act quickly. If you notice any unusual symptoms or feel unwell after swallowing too much, don’t hesitate to reach out for help. Your safety is the top priority, so getting prompt medical advice is essential.

Pregnancy Use

Safety during pregnancy has not been established for this medication, so it's important to approach its use with caution. There are no specific contraindications listed, but due to the lack of established safety, you should consult your healthcare provider before using it if you are pregnant or planning to become pregnant.

Currently, there is no detailed information available regarding potential risks to the fetus, and no dosage modifications or special precautions are provided for pregnant individuals. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and 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 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 reach of children under 6 years old. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly after meals or at least twice a day, following the guidance of a dentist or physician.

If your child is under 6 years old, use only a pea-sized amount to help minimize swallowing, and be sure to supervise their brushing and rinsing until they develop good habits. For children under 2 years, 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. This means that, in general, you can take this medication without worrying about it affecting other treatments or test results.

However, it's always important to discuss any medications you are taking or any upcoming lab tests with your healthcare provider. They can provide personalized advice and ensure that your treatment plan is safe and effective for you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15º-35ºC (59º-95ºF). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands or gloves to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. Taking these precautions will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is 5900 Clear Mint, Gel Toothpaste used for?

It helps protect against cavities.

What should adults and children 2 years of age and older do with this toothpaste?

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

How should I use this toothpaste for children under 6 years?

Use a pea-sized amount and supervise the child's brushing and rinsing until good habits are established.

What should I do if I accidentally swallow more than the amount used for brushing?

Get medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

Is this toothpaste safe to use during pregnancy?

Safety during pregnancy has not been established, so caution is advised.

Are there any contraindications for using this toothpaste?

No specific contraindications are mentioned, but caution is advised due to the lack of established safety.

What should I do if my child is under 2 years old?

Ask a dentist or physician before use.

How should I store 5900 Clear Mint, Gel Toothpaste?

Store it between 15º-35ºC (59º-95ºF).

Are there any known drug interactions with this toothpaste?

No drug interactions were found in the provided text.

Is there any information about the use of this toothpaste by nursing mothers?

There are no specific warnings or recommendations regarding its use by nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Sodium Fluoride (clear mint, gel toothpaste). 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

5900 Clear Mint is a gel toothpaste formulation designed for oral hygiene. It features a clear appearance and is infused with a mint flavor to enhance user experience. The product is specifically formulated to provide effective cleaning and protection for teeth.

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 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is recommended to use a pea-sized amount of the product to minimize the risk of swallowing. Caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established.

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

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to mitigate potential health risks associated with excessive consumption.

This product must be stored securely and kept out of reach of children under the age of 6 years. Ensuring that this product is inaccessible to young children is essential to prevent accidental ingestion and associated health hazards.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Additionally, it is crucial to keep this product out of reach of children, particularly those under 6 years of age, to prevent any unintended exposure or adverse effects.

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 (clear mint, gel toothpaste). 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. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist or physician.

In children under 6 years, to minimize the risk of swallowing, a pea-sized amount should be used, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established. For infants and children under 2 years, consultation with a dentist or physician is advised 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

Safety during pregnancy has not been established for this medication. While there are no specific contraindications noted, caution is advised due to the lack of established safety data. Currently, there is no specific information available regarding risks to the fetus associated with the use of this medication during pregnancy. Additionally, there are no dosage modifications recommended for pregnant individuals, nor are there any special precautions outlined for use in this population. Healthcare professionals should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients or women of childbearing potential.

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 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 overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, it is crucial to seek immediate medical assistance. If an individual accidentally ingests more than the recommended amount used for brushing, they should contact a healthcare professional or reach out to a Poison Control Center at 1-800-222-1222 without delay.

Prompt action is essential to ensure the safety and well-being of the individual affected by the overdosage. Healthcare providers should be prepared to assess the situation and provide appropriate management based on the specific circumstances of the 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 15º to 35ºC (59º to 95ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

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.

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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.