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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
69423-920

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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 your 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 taste of wild peppermint.

This product is labeled as "ENAMEL CARE," emphasizing its role in maintaining and nourishing your teeth. With a net weight of 3.7 ounces (104 grams), it offers a straightforward solution for daily dental hygiene, helping you keep your smile healthy and bright.

Uses

You can use this product to help protect your teeth against cavities. It contains fluoride, which is specifically designed to remineralize (restore minerals to) your enamel, prevent cavities, and nourish your teeth. This means that not only does it help keep your teeth strong, but it also works to repair any early signs of damage.

Rest assured, there are no concerns regarding teratogenic effects (harmful effects on fetal development) associated with this product, making it a safe choice for your dental care routine.

Dosage and Administration

It's important to take care of your teeth, and brushing is a key part of that routine. 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 ensures that you are 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 risks.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent 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.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

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 Theory Enamel Care Wild Peppermint (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 always best to consult with your healthcare provider before using any new products, including dental care items, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to note that there is no specific information available about the use of Theory Enamel Care Wild Peppermint for nursing mothers. This means that the effects on breast milk or your nursing infant are not clearly defined.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure the safety and well-being of both you and your baby.

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 the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, you should help them brush their teeth thoroughly after meals or at least twice a day, following your dentist's advice.

To reduce the risk of 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

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how to manage your treatment effectively.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

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 feel free to ask questions and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. Avoid freezing, as this can damage the device. When you're not using the tube, make sure to keep it tightly closed to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. 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 used for brushing, seek medical help or contact a Poison Control Center immediately. To reduce the risk of swallowing, use only a pea-sized amount for children under 6 and supervise their brushing until they develop good habits. For children under 2 years old, consult a dentist before use.

FAQ

What is fluoride anticavity toothpaste used for?

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

What are the key ingredients in this toothpaste?

The toothpaste is made with fluoride and contains no extraneous ingredients, dyes, parabens, or SLS. It has a real mint flavor.

Who can use fluoride anticavity toothpaste?

Adults and children 2 years and older can use it. Children under 2 years should consult a dentist.

How should I use this toothpaste?

Brush your teeth thoroughly after meals or at least twice a day, using a pea-sized amount for children under 6 to minimize swallowing.

Are there any warnings associated with this toothpaste?

Yes, keep it out of reach of children under 6 years. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center.

Is there any information about using this toothpaste during pregnancy or while nursing?

The product insert does not provide specific information regarding use during pregnancy or nursing.

How should I store fluoride anticavity toothpaste?

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

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

Fluoride anticavity toothpaste formulated for enamel care, featuring a wild peppermint flavor. This product is designed with a scientific approach, utilizing fluoride to remineralize enamel, prevent cavities, and nourish teeth. It contains no extraneous ingredients and is free from dyes, parabens, and sodium lauryl sulfate (SLS). Additionally, the formulation does not include any added artificial flavors, relying solely on real mint for its taste.

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 daily, or as directed by a dentist. It is important to ensure 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 and product use.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 aware of the following warnings and precautions associated with the use of this product. It is imperative to keep the product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of patients, particularly in young children who may be more susceptible to adverse effects from improper use.

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 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. It is recommended that a pea-sized amount of the product be used to minimize swallowing in this age group. 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.

For children under 2 years of age, consultation with a dentist is advised prior to use. Care should be taken to keep the product out of reach of young children. In the event that more than the recommended amount is accidentally swallowed, medical assistance or contact with a Poison Control Center is necessary. It is important to instruct pediatric patients not to swallow the product.

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 Enamel Care Wild Peppermint (sodium fluoride paste, dentifrice) during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Theory Enamel Care Wild Peppermint. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers, as the effects on breastfed infants are not established.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 outlined 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 an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount 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 related to the specific substance involved is essential, and appropriate management procedures should be initiated based on clinical judgment and established protocols.

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 product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

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, avoiding exposure to freezing conditions. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients 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 should seek medical assistance or contact a Poison Control Center immediately. To minimize swallowing, it is recommended that a pea-sized amount be used for children under 6 years, and parents should supervise children's brushing until proper habits are established. For children under 2 years, consultation with a dentist is advised.

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

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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.