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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 2020
Label revision date
February 2, 2026
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 2020
Label revision date
February 2, 2026
Manufacturer
Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-835

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

Drug Overview

BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste is a dental care product designed to help you maintain oral health. It works by preventing cavities, deep cleaning your teeth, freshening your breath, gently whitening your smile, and removing stains. Additionally, it strengthens tooth enamel, making it a comprehensive choice for your daily dental hygiene routine. This toothpaste is accepted by the American Dental Association (ADA), ensuring its effectiveness and safety for your teeth.

What sets BURT'S BEES toothpaste apart is its commitment to natural ingredients, as it is made without sodium lauryl sulfate (SLS), artificial flavors, or sweeteners, and it has not been tested on animals. This makes it a thoughtful option for those looking for a more natural approach to oral care while still achieving great results.

Uses

You can use this product to help protect your teeth against cavities. It works by strengthening your enamel and creating a barrier that helps prevent decay.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe option for most users.

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 old 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 the chance of 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 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.

Please be aware of these warnings to ensure safety while using the product.

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, and if you have any concerns or experience unusual symptoms, stop using it and call your doctor for 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 Burt's Bees Complete Multi-Care Sodium Fluoride 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 about any products you use, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation (the process of producing milk). This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

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.

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

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 for personalized advice. They can help determine the best approach to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it. When not in use, make sure to keep the tube tightly closed to maintain its integrity. 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. Following these guidelines will help you handle the product safely and effectively.

Additional Information

The medication is administered through the dental route, meaning it is used in the mouth. It's important that you do not swallow the medication. If you are using it for children under 6 years old, use only a pea-sized amount to help minimize swallowing. Additionally, make sure to supervise children while they are brushing their teeth until they develop good habits.

FAQ

What is BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste used for?

It helps protect against cavities, deep cleans, freshens breath, gently whitens, removes stains, and strengthens enamel.

Is BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste safe for children?

Yes, it is suitable for adults and children 2 years and older. However, children under 6 should use a pea-sized amount and be supervised while brushing.

Are there any contraindications for using this toothpaste?

No contraindications are listed for BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste.

What should I do if more toothpaste is accidentally swallowed?

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

Can I use BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste during pregnancy?

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

How should I store BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste?

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

Is BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste tested on animals?

No, it is not tested on animals.

What is the packaging size of BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste?

It comes in a tube with a net weight of 4.7 oz (133 g).

Does BURT'S BEES Complete Multi-Care FLUORIDE Toothpaste contain artificial ingredients?

No, it is made without SLS, artificial flavors, and sweeteners.

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 specified drug.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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 of age, 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 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 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 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 more susceptible to adverse effects from improper use.

Drug Interactions

There are currently no documented drug interactions associated with 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 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 to minimize swallowing in this age group. 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, immediate medical assistance or contact with a Poison Control Center is necessary. For children under 2 years of age, consultation with a dentist is recommended prior to use.

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 regarding the use of Burt's Bees Complete Multi-Care Sodium Fluoride Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise clinical judgment when recommending this product to women of childbearing potential. It is advisable to consider the overall oral health needs of pregnant patients and to discuss any concerns they may have regarding the use of fluoride-containing products during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns based on the available data.

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 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.

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.

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 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 that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. When not in use, the tube should be kept tightly closed to prevent contamination and degradation. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this time frame is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients not to swallow the product. For children under the age of 6, it is recommended to use a pea-sized amount to minimize swallowing, and caregivers should supervise children's brushing until proper oral hygiene habits are established.

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.