ADD CONDITION

items per page

Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
October 29, 2025
Active ingredient
Sodium Fluoride 0.243 g/100 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 2025
Label revision date
October 29, 2025
Manufacturer
HISMILE PTY LTD
Registration number
M021
NDC root
83013-341

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

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, which can help maintain your oral health and reduce the risk of tooth decay. By using this product as directed, you can take an important step towards keeping your smile healthy and bright.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities. Regular use is an important step in maintaining a healthy smile.

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. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. It's also a good idea to supervise them while they brush until they can do it on their own.

If you have a child who is under 2 years old, it's best to consult a dentist or doctor for guidance on how to care for their teeth properly. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. You should not swallow the medication or use it in the eye area, as these actions can lead to unwanted effects.

While there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence, adhering to these instructions is crucial for your well-being. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of some key safety information regarding this product. You should never swallow it or use it near your eyes. Additionally, keep it out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. If you accidentally swallow more than what is typically used for brushing your teeth, seek medical help immediately or contact a Poison Control Center.

There are no specific laboratory tests required for this product, but always prioritize your safety and well-being. 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 what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, 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

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to discuss your options with your healthcare provider. They can help you understand any potential risks and determine the best course of action for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

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 using medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children in this age group, you should teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children until they can use it safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use. For children aged 2 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, or follow the guidance of a healthcare professional.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it, as extreme cold can damage the device. When not in use, make sure to keep the tube tightly closed to maintain its integrity and prevent contamination. If you open the product but do not use it within a specified time frame, be sure to discard it to ensure safety and effectiveness.

Additional Information

The medication is administered through the dental route, meaning it is used in the mouth. It is important that you do not swallow the medication. If you are giving this medication to a child under 6 years old, make sure to teach them proper brushing and rinsing habits to help prevent swallowing. Additionally, supervise young children while they are using the medication until they are able to do so safely on their own.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 2 years and older use this product?

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

What should I do if my child is under 6 years old?

Instruct them in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

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

Get medical help or contact a Poison Control Center right away.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug safe for use during pregnancy or by nursing mothers?

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

What precautions should I take when using this product?

Do not swallow the product and do not use it in the eye area.

How should I store this product?

Store at room temperature, do not freeze, and keep the tube tightly closed when not in use.

What should I do if I have questions about using this product?

Consult your dentist or doctor for guidance on proper use.

Packaging Info

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

Packaging configurations for Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

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 under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as it may lead to adverse effects. Additionally, application in the eye area is contraindicated due to the potential for irritation or injury.

Warnings and Precautions

The product is intended for external use only and should not be swallowed. It is imperative to avoid application in the eye area to prevent potential irritation or injury.

In the event that an excessive amount, beyond what is typically used for brushing, is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product. However, vigilance is essential in observing any adverse reactions or complications that may arise from improper use.

Should any concerning symptoms develop, it is advisable to discontinue use and consult a healthcare provider for further evaluation and guidance.

Side Effects

Patients should be advised of the following warnings regarding the use of this product. It is critical that the product is not swallowed and is not used in the eye area. Additionally, it is important to keep the 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 swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct children in this age group on proper brushing and rinsing techniques to minimize swallowing. Supervision is recommended until children are capable of using the product without assistance.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use. For those aged 2 years and older, it is recommended that they brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

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 available 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.

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 from the use of this product during lactation.

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 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 hepatic impairment.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and specific antidotes if applicable.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will facilitate optimal patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product and to use it only as directed for brushing. Instruct patients that if they accidentally swallow more than the recommended amount, they should seek medical assistance or contact a Poison Control Center immediately. Additionally, it is important to inform patients not to use the product in the eye area to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use. It is essential to store the product at room temperature and to avoid freezing. Additionally, any unused product should be discarded after opening, adhering to the specified time frame for safe usage, although this time frame is not detailed in the provided information.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients not to swallow the product. It is important to instruct children under 6 years of age on proper brushing and rinsing techniques to minimize the risk of swallowing. Additionally, supervision of children is recommended until they are capable of using the product without assistance.

Drug Information (PDF)

This file contains official product information for Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast, 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 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast, 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.