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Theory

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This product has been discontinued

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
August 6, 2025
Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
August 6, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-919

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If you are a consumer or patient please visit this version.

Drug Overview

Fluoride anticavity toothpaste is a specially formulated dental product designed to help protect your teeth from cavities. It contains fluoride, which works to remineralize tooth enamel, making it stronger and more resistant to decay. This toothpaste is crafted with a focus on effectiveness, using only essential ingredients without dyes, parabens, or artificial flavors—just a refreshing real mint taste.

By using fluoride anticavity toothpaste regularly, you can support your dental health and keep your smile bright. Its simple yet powerful formulation is aimed at nourishing your teeth and preventing cavities, ensuring that your oral care routine is both effective and pleasant.

Uses

You can use this product to help protect your teeth against cavities. It contains fluoride, which plays a key role in remineralizing (restoring minerals to) your tooth enamel, preventing cavities, and nourishing your teeth. This means that not only does it help keep your teeth strong, but it also supports their overall health.

Dosage and Administration

It's important to take care of your teeth, and using the right amount of toothpaste is a key part of that. If you are an adult or have a child who is 2 years or older, you should brush your teeth thoroughly after meals or at least twice a day. If your dentist has given you specific instructions, be sure to follow those as well. Remember, do not swallow the toothpaste. For children under 6, use only a pea-sized amount to help minimize swallowing, and supervise their brushing until they develop good habits.

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

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always follow the usage instructions carefully to ensure your safety and well-being.

Side Effects

It's important to keep this product 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.

Always be cautious and ensure that this product is used as directed to avoid any potential issues.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, don't hesitate to stop using it and call your doctor for advice. Your health and safety are the top priority.

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

There is currently no specific information available regarding the use of Theory Freshness Care Essential Mint (sodium fluoride paste, dentifrice) 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’s important to consult with your healthcare provider before using this product. They can provide personalized advice and help you make informed decisions about your dental care during this time.

Lactation Use

There is no specific information available about the use of Theory Freshness Care Essential Mint (sodium fluoride paste, dentifrice) for nursing mothers or during lactation. This means that if you are breastfeeding, you should consult your healthcare provider for personalized advice regarding the use of this product. They can help you understand any potential effects on your milk production or your nursing infant. Always prioritize your health and your baby's well-being when considering any new products.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly after meals or at least twice a day, following your dentist's instructions.

To help prevent swallowing, use only a pea-sized amount for children under 6, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult with a dentist before use.

Geriatric Use

While there is no specific information about how this medication should be used by 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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

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. If you open the tube and do not use the contents within a certain period, it is important to discard it to ensure safety and effectiveness. Always follow these guidelines to handle the product safely and effectively.

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 is used or its effects, be sure to consult your healthcare provider.

FAQ

What is fluoride anticavity toothpaste used for?

Fluoride anticavity toothpaste helps protect against cavities by remineralizing enamel and nourishing teeth.

What ingredients are in fluoride anticavity toothpaste?

It is made with fluoride and contains no extraneous ingredients, dyes, parabens, or SLS. It has no added artificial flavors, only real mint.

How should I use fluoride anticavity toothpaste?

Adults and children 2 years and older should brush their teeth thoroughly after meals or at least twice a day. Use a pea-sized amount for children under 6 and supervise their brushing.

Are there any warnings for fluoride anticavity toothpaste?

Keep fluoride anticavity toothpaste out of reach of children under 6 years of age. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center.

Is fluoride anticavity toothpaste safe during pregnancy or breastfeeding?

The drug insert does not provide specific information regarding safety concerns or precautions for use during pregnancy or breastfeeding.

How should fluoride anticavity toothpaste be stored?

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

Are there any contraindications for using fluoride anticavity toothpaste?

No contraindications are listed for fluoride anticavity toothpaste.

What should I do if I accidentally swallow fluoride anticavity toothpaste?

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

Packaging Info

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

Packaging configurations for Theory.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This fluoride anticavity toothpaste, weighing 3.7 oz (104 g), is formulated to provide effective dental care through its scientifically designed composition. It contains fluoride, which aids in the remineralization of enamel, prevention of cavities, and nourishment of teeth. The product is characterized by its essential mint flavor, derived from real mint without the inclusion of added artificial flavors. Additionally, it is free from dyes, parabens, and sodium lauryl sulfate (SLS), ensuring a formulation that focuses solely on essential ingredients for optimal oral health.

Uses and Indications

This drug is indicated for the protection against dental cavities. It is formulated with fluoride, which aids in the remineralization of enamel, thereby preventing cavities and nourishing teeth.

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

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important that the product is not swallowed. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Caregivers should supervise the brushing of children's teeth until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care.

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount for brushing is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be at greater risk of adverse reactions from improper use.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Theory (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theory.
Details

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. A pea-sized amount of the product is recommended for children in this age group to minimize swallowing. It is advised that children under 2 years of age consult a dentist before use.

For children aged 2 years and older, the product should be used to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important to instruct pediatric patients not to swallow the product. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is necessary.

Additionally, the product should be kept out of reach of children under 6 years of age to prevent accidental ingestion.

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 Theory Freshness Care Essential Mint (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There is no specific information regarding the use of Theory Freshness Care Essential Mint (sodium fluoride paste, dentifrice) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding 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.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the product's quality, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within a specified period, which is not detailed in the provided information.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Theory, 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 Theory, 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.