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Firefly Anticavity Fluoride

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Active ingredient
Sodium Fluoride .5 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
November 25, 2024
Active ingredient
Sodium Fluoride .5 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
November 25, 2024
Manufacturer
Ranir LLC
Registration number
M021
NDC root
66923-007

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Drug Overview

FIREFLY ANTICAVITY Fluoride Rinse is a mouthwash designed to help prevent dental cavities. It contains fluoride, which is a mineral that strengthens tooth enamel and makes it more resistant to decay. This rinse is alcohol-free and has been accepted by the American Dental Association (ADA), ensuring its effectiveness and safety for maintaining oral health.

Using this fluoride rinse can be a simple and effective way to support your dental hygiene routine and protect your teeth from cavities.

Uses

You can use this product to help prevent dental cavities. It works effectively to reduce the risk of developing cavities, which are small holes in your teeth caused by decay. By incorporating this into your dental care routine, you can support your oral health and maintain a brighter smile.

Rest assured, there are no known teratogenic effects (harmful effects on the developing fetus) associated with this product, making it a safe option for most users.

Dosage and Administration

After brushing your teeth with toothpaste, you can use this mouth rinse once a day. For adults and children aged 6 years and older, take 10 milliliters of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. It’s very important that you do not swallow the rinse. After using the rinse, avoid eating or drinking anything for 30 minutes to allow the product to work effectively.

If you’re helping a child under 12 years old, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise them until they can use it safely on their own. For children under 6 years old, it’s best to consult a dentist or doctor before using the 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 more than the recommended 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

If you accidentally swallow more of this product than intended for rinsing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more than the amount 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 address any potential health risks.

Currently, there are no specific general precautions or laboratory tests associated with this product. However, always stay informed and cautious when using any medication or treatment. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can help ensure your safety.

Signs of an overdose may not be obvious, 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

There is currently no specific information available regarding the use of FIREFLY Anticavity Fluoride Rinse during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including mouth rinses, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use FIREFLY Anticavity Fluoride Rinse without specific warnings or recommendations to be concerned about. The information available does not indicate any precautions related to lactation (the process of producing milk) or any potential effects on breast milk.

Feel confident in your choice, as there are no noted risks associated with using this product while nursing. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

It's important to keep this mouth rinse out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, the rinse can be used once a day after brushing teeth. They should swish 10 milliliters of the rinse between their teeth for 1 minute and then spit it out, making sure not to swallow it.

For children under 12, it's essential to teach them proper rinsing habits to reduce the chance of swallowing the rinse. 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. Additionally, remind children not to eat or drink for 30 minutes after rinsing to ensure the rinse works effectively.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the available information. This means that the standard recommendations for the medication may apply to you, but it’s always best to consult with your healthcare provider. They can give you personalized advice based on your liver function and overall health. Always keep them informed about your liver condition to ensure safe and effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to check that the printed plastic neckband is intact. If it is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always follow these guidelines to ensure proper use and care.

Additional Information

No further information is available.

FAQ

What is FIREFLY ANTICAVITY Fluoride Rinse used for?

FIREFLY ANTICAVITY Fluoride Rinse aids in the prevention of dental cavities.

Is FIREFLY ANTICAVITY Fluoride Rinse alcohol-free?

Yes, FIREFLY ANTICAVITY Fluoride Rinse is alcohol-free.

What is the recommended usage for adults and children 6 years and older?

Use once a day after brushing your teeth, swish 10 milliliters of rinse between your teeth for 1 minute, and then spit it out. Do not swallow the rinse.

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

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Can children under 6 years use this rinse?

Children under 6 years of age should consult a dentist or doctor before use.

Are there any contraindications for using FIREFLY ANTICAVITY Fluoride Rinse?

No contraindications are listed for FIREFLY ANTICAVITY Fluoride Rinse.

What precautions should I take when using this rinse?

Keep out of reach of children and do not eat or drink for 30 minutes after rinsing.

What is the recommended storage temperature for this product?

Store FIREFLY ANTICAVITY Fluoride Rinse at a temperature between 59°-86°F (15°-30°C).

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

No specific information regarding the use of FIREFLY ANTICAVITY Fluoride Rinse during pregnancy or lactation is provided.

Packaging Info

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

Packaging configurations for Firefly Anticavity Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

FIREFLY® ANTICAVITY Fluoride Rinse is a dental rinse formulated to help prevent cavities. It is presented in a 16 FL OZ (473 mL) dosage form and features a WILD MELON flavor. This product is alcohol-free and has received acceptance from the American Dental Association® (ADA).

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in reducing the incidence of cavities in the target population.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 milliliters of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Following the rinsing procedure, patients should refrain from eating or drinking for a period of 30 minutes 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 demonstrates the ability to use the rinse without assistance. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek immediate medical assistance or contact a Poison Control Center.

Warnings and Precautions

In the event that more than the recommended amount used for rinsing is accidentally ingested, immediate medical assistance should be sought. It is imperative 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, healthcare professionals should remain vigilant and ensure that patients are aware of the potential risks associated with accidental ingestion.

Side Effects

Patients should be aware that if more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Firefly Anticavity Fluoride.
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. They should vigorously swish 10 milliliters of the rinse between their teeth for 1 minute and then spit it out. It is crucial to emphasize that the rinse should not be swallowed, and children should refrain from eating or drinking for 30 minutes following rinsing.

Children under 12 years of age should be guided in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be necessary until the child is capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information available 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 FIREFLY Anticavity Fluoride Rinse during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of FIREFLY Anticavity Fluoride Rinse by lactating mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

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 information available regarding hepatic impairment, including dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise caution and consider individual patient circumstances 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 swiftly in such situations to ensure their safety.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product within the recommended temperature range of 59°F to 86°F (15°C to 30°C) to maintain its integrity and efficacy.

Care should be taken to ensure that the printed plastic neckband remains intact; the product should not be used if this neckband is broken or missing, as this may indicate tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Firefly Anticavity 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 Firefly Anticavity 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.