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Fluoride Gel

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
July 7, 2016
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2015
Label revision date
July 7, 2016
Manufacturer
Yangzhou Hengyuan Daily Chemical Plastic Co. , Ltd
Registration number
part356
NDC root
51289-400

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

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this drug, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

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) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

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 2 years and older. If you're helping a child between the ages of 2 and 6, make sure to use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before starting any brushing routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. Always ensure that this product is stored safely to prevent any accidental ingestion.

Warnings and Precautions

It's important to keep this product out of the reach of children, especially those under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center right away.

Always ensure that this product is stored safely to prevent any accidental ingestion. Your safety and the safety of your loved ones is a priority, so please take these precautions seriously.

Overdose

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 medical help or contact a Poison Control Center right away.

Signs of an overdose can include unusual symptoms, so it's crucial to act quickly if you suspect an overdose has occurred. Always prioritize safety and don't hesitate to reach out for professional assistance in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding 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. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

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. For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician.

For children aged 2 to 6 years, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of swallowing. If your child is under 2 years old, it's best to 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, 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined 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, who can offer personalized guidance based on your individual situation.

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 like you.

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 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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What does this drug do?

This drug helps protect against cavities.

What are the instructions for using this drug?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day. Children 2-6 years should use only a pea-sized amount and be supervised while brushing.

What should I do if a child under 2 years needs to use this drug?

For children under 2 years, you should ask a dentist or a physician before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if more than the recommended amount is swallowed?

If more than the recommended amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

Is this drug safe for children?

Keep this drug out of reach of children under 6 years of age.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

Packaging Info

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

Packaging configurations for Fluoride Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is formulated as a tablet. Specific details regarding the chemical name, physical characteristics, and inactive ingredients are not provided.

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, 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 recommended prior to use.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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 a Poison Control Center without delay.

Additionally, general precautions should be observed to ensure the safety of all children. This product should be stored securely and kept out of reach of children at all times to prevent accidental ingestion or misuse.

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 is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, the product should always be stored safely to prevent accidental ingestion by children. The importance of these precautions cannot be overstated, as they are essential for ensuring the safety and well-being of young children.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Fluoride Gel (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fluoride Gel.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 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. In 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 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 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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

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 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 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 reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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