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Burts Bees

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Active ingredient
Sodium Fluoride 1.3 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
April 10, 2025
Active ingredient
Sodium Fluoride 1.3 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
April 10, 2025
Manufacturer
Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-961

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Drug Overview

BURT'S BEES® FLUORIDE Toothpaste is a specially formulated toothpaste designed to provide a deep clean while also whitening your teeth. It helps protect against cavities and enamel erosion, ensuring your smile stays healthy and bright. Additionally, this toothpaste freshens your breath, making it a great choice for your daily oral care routine.

This product is accepted by the American Dental Association (ADA), which means it meets high standards for safety and effectiveness. BURT'S BEES® FLUORIDE Toothpaste is made without sodium lauryl sulfate (SLS), artificial flavors, or sweeteners, and it has not been tested on animals, aligning with a commitment to natural and ethical ingredients.

Uses

Using this product can be beneficial for your dental health in several ways. It helps protect against cavities, which are small holes in your teeth caused by decay. By preventing cavities, it plays a crucial role in maintaining your overall oral hygiene.

Additionally, this product protects your enamel, the hard outer layer of your teeth that shields them from damage. It also freshens your breath, leaving you with a clean and pleasant feeling. Incorporating this into your routine can contribute to a healthier smile and better breath.

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, make sure to brush your teeth thoroughly after meals or at least twice a day. You can also follow any specific instructions given by your dentist. Remember, do not swallow the toothpaste.

For children under 6, use only a pea-sized amount of toothpaste to help minimize swallowing. It's a good idea to supervise young children while they brush their teeth until they develop good habits. If your child is under 2 years old, it's best to consult with a dentist for guidance on how to care for their teeth.

What to Avoid

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, seek medical help or contact a Poison Control Center immediately.

While there are no specific contraindications or concerns regarding controlled substances, abuse, or dependence associated with this product, always use it as directed to avoid any potential issues. Your safety is a priority, so please follow these guidelines carefully.

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 aware of how to use this product safely to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of the 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 and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product 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 always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Remember, your well-being is the top priority.

Pregnancy Use

There is currently no specific information available regarding the use of Burt's Bees Deep Clean + Whitening toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take while pregnant.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider before using any new products, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult with a healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means you should be cautious when considering its use while nursing. Additionally, the safety of this product during lactation has not been established, so it's essential to weigh the potential risks and benefits with your doctor.

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 used 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.

When using this product 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, consult with a dentist before use.

Geriatric Use

While there is no specific information about the use of Burt's Bees Deep Clean Plus Whitening toothpaste in older adults, it's always wise to approach new products with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you can generally use the product as directed. However, if you have any underlying health conditions or are taking other medications, it’s a good idea to consult with your healthcare provider before starting any new oral care products. This ensures that you are making the best choice for your health and well-being.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

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

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 keep it away from freezing conditions. It's important to handle the product carefully and to discard it after opening to maintain safety and effectiveness. Following these guidelines will help you use 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 BURT'S BEES® FLUORIDE Toothpaste used for?

BURT'S BEES® FLUORIDE Toothpaste helps protect against cavities, prevents cavities, protects enamel, and freshens breath.

Is BURT'S BEES® FLUORIDE Toothpaste safe for children?

Children under 2 years should ask a dentist before use. For children under 6, use a pea-sized amount and supervise brushing.

What should I do if my child swallows BURT'S BEES® FLUORIDE Toothpaste?

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

Can I use BURT'S BEES® FLUORIDE Toothpaste while pregnant or breastfeeding?

Consult a healthcare professional before using this product during pregnancy or while breastfeeding, as safety has not been established.

What are the storage instructions for BURT'S BEES® FLUORIDE Toothpaste?

Store at room temperature, protect from freezing, and discard after opening.

Is BURT'S BEES® FLUORIDE Toothpaste tested on animals?

No, BURT'S BEES® FLUORIDE Toothpaste is not tested on animals.

What is the packaging size of BURT'S BEES® FLUORIDE Toothpaste?

It comes in a 133 g tube, which is approximately 4.7 ounces.

Does BURT'S BEES® FLUORIDE Toothpaste contain artificial ingredients?

No, it is made without SLS (sodium lauryl sulfate), artificial flavors, and sweeteners.

Is there any information on drug interactions with BURT'S BEES® FLUORIDE Toothpaste?

No drug interactions information is provided for BURT'S BEES® FLUORIDE Toothpaste.

Packaging Info

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

Packaging configurations for Burts Bees.
Details

Drug Information (PDF)

This file contains official product information for Burts Bees, 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 and the protection of tooth enamel. It also serves to freshen breath, contributing to overall oral health.

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 during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of teeth in children until proper oral hygiene habits are established.

For children under 2 years, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, it is advised to keep the product out of reach of this age group. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 associated with the use of this product. It is crucial 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 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 more susceptible to adverse effects from improper use.

Drug Interactions

There are currently no documented drug interactions associated with 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 Burts Bees (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burts Bees.
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 in children under 6 to minimize swallowing. For children aged 2 years and older, it is advised to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist.

Parents and caregivers should keep the product out of reach of children under 6 years. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately. For children under 2 years of age, consultation with a dentist is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of Burt's Bees Deep Clean Plus Whitening toothpaste in geriatric patients. The drug insert does not provide details on dosage adjustments, safety concerns, or special precautions that may be applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when recommending this product to geriatric patients, considering the absence of targeted data for this population. Monitoring for any adverse effects or reactions may be prudent, given the lack of specific guidance.

Pregnancy

There is no specific information regarding the use of Burt's Bees Deep Clean + Whitening toothpaste 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.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when using this product while breastfeeding. The safety of this product during lactation has not been 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, 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 specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 this product out of the 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, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in case of an emergency.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Burts Bees, 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 Burts Bees, 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.