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Prime Tooth Care Blueberry

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Active ingredient
Sodium Fluoride 2.5 mg/1 g
Other brand names
Dosage form
Ointment
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 9, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 2.5 mg/1 g
Other brand names
Dosage form
Ointment
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 9, 2026
Manufacturer
Prime Tooth Care LLC
Registration number
M021
NDC root
87053-001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 product, 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.

Additionally, there are no concerns regarding teratogenic effects (which means it does not 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 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 prevent swallowing toothpaste. You should supervise younger children 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.

By following these guidelines, you can help ensure safe use of the product.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. Keep it out of reach of children under 6 years old to prevent accidental ingestion.

If you accidentally swallow more than what is needed for brushing, seek emergency medical help or contact a Poison Control Center immediately. Always prioritize safety and be aware of how to use the product correctly.

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 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 about the use of PRIME TOOTH CARE BLUEBERRY sodium fluoride ointment 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 important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the information provided does not include specific guidelines or considerations for nursing mothers or lactation (the process of producing milk). This means that there are no detailed recommendations or warnings regarding the use of any medications or substances while you are nursing.

Always consult with your healthcare provider for personalized advice and to ensure the safety of both you and your baby while breastfeeding. They can provide guidance based on your individual situation and any medications you may be considering.

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 while they use it until they can do so safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor before using this product. This ensures that you are making the safest choices for your child's health.

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

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

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You will use this medication through a dental route, which means it is applied in the mouth. If you have children under 6 years old, it's important to teach them good brushing and rinsing habits to help prevent swallowing the medication. You should supervise younger children until they can use it safely on their own. For children under 2 years old, it's best to consult a dentist or doctor before use.

FAQ

What is the primary use of this drug?

This drug helps protect against cavities.

What should I do if a child under 6 years old uses this drug?

Instruct children under 6 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?

If more than used for brushing is accidentally 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.

Can this drug be used by children under 2 years of age?

Consult a dentist or doctor before using this drug for children under 2 years of age.

What precautions should I take when using this drug?

Do not swallow the drug and do not use it in the eye area. Keep it out of reach of children under 6 years of age.

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Prime Tooth Care Blueberry.
Details

Drug Information (PDF)

This file contains official product information for Prime Tooth Care Blueberry, 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 specified drug.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, it is recommended to consult a dentist or doctor 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

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is not intended for ingestion; it must not be swallowed. Additionally, it should not be applied in the eye area, as this may lead to adverse effects.

General Precautions To ensure safety, this product should be kept out of the reach of children under 6 years of age.

Emergency Medical Assistance In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Discontinuation of Use Patients are advised to stop using the product and consult their healthcare provider if any concerning symptoms arise, although specific instructions for discontinuation were not provided in the available information.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area. Additionally, it is crucial to keep the product out of reach of children under 6 years of age.

In the event that more than the recommended amount for brushing is accidentally swallowed, patients are advised to seek medical help or contact a Poison Control Center immediately. These precautions are essential to ensure the safety and well-being of users, particularly young children.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Prime Tooth Care Blueberry.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct these children in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product independently.

For children under 2 years of age, consultation with a dentist or doctor 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

There is no specific information regarding the use of PRIME TOOTH CARE BLUEBERRY sodium fluoride ointment during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when prescribing this ointment to women of childbearing potential.

Lactation

There are no specific statements or considerations regarding nursing mothers or lactation in the provided text. Therefore, the effects of the drug on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks and benefits have not been established.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data may necessitate careful monitoring and assessment of the patient's overall health status.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 reach of children under 6 years of age to prevent accidental ingestion. It is important to inform patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against swallowing the product and should be instructed not to use it in the eye area to avoid potential irritation or injury. Clear communication of these points will help ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize the risk of swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

This file contains official product information for Prime Tooth Care Blueberry, 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 Prime Tooth Care Blueberry, 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.