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Burts Bees Kids

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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 2023
Label revision date
August 6, 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 2023
Label revision date
August 6, 2025
Manufacturer
Procter & Gamble Manufacturing Company
Registration number
M021
NDC root
69423-819

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

Burt's Bees Fluoride Toothpaste is a specially formulated toothpaste designed for kids, featuring a delightful Strawberry Splash flavor that makes brushing enjoyable. This toothpaste helps protect against cavities, ensuring your child's dental health is supported while they enjoy a great-tasting experience. It is also dye-free and has been accepted by the American Dental Association (ADA), reflecting its quality and effectiveness. Plus, you can feel good knowing that it has not been tested on animals.

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.

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

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow these guidelines or any specific instructions given by your dentist. Remember, you should not swallow the toothpaste.

For children under 6 years old, use only a pea-sized amount of toothpaste to help minimize swallowing. It's also 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, be sure to consult with a dentist for the best advice on dental care.

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 use this product as directed to ensure safety and effectiveness. If you have any concerns about its use, please consult with a healthcare professional.

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 be aware of any unusual reactions. If you experience any concerning symptoms, 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 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 information available about the use of Burt's Bees Kids Strawberry Splash (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 product's insert.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and 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 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 helping younger children brush, use only a pea-sized amount to minimize swallowing, and supervise them until they develop good brushing habits. If your child is under 2 years old, consult with a dentist before using this product.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 you understand any necessary precautions or adjustments based on your kidney 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 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 avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use 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 the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children under 6, use only a pea-sized amount to minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult a dentist before use.

FAQ

What is Burt's Bees fluoride toothpaste?

Burt's Bees fluoride toothpaste is a dental product designed for kids, featuring an improved formula in a Strawberry Splash flavor that helps prevent cavities.

Is Burt's Bees fluoride toothpaste safe for children?

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

What should I do if my child accidentally swallows the toothpaste?

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

Is this toothpaste tested on animals?

No, Burt's Bees fluoride toothpaste is not tested on animals.

How should I store Burt's Bees fluoride toothpaste?

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

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

The provided information does not include specific warnings or recommendations regarding use during pregnancy or lactation.

What is the net weight of Burt's Bees fluoride toothpaste?

The net weight of the toothpaste is 4.7 oz (133 g).

Is Burt's Bees fluoride toothpaste accepted by dental associations?

Yes, it is accepted by the American Dental Association (ADA).

Packaging Info

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

Packaging configurations for Burts Bees Kids.
Details

Drug Information (PDF)

This file contains official product information for Burts Bees Kids, 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 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 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, 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 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 Kids (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burts Bees Kids.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years.

Supervision of children's brushing is essential until good oral hygiene habits are established. 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Burt's Bees Kids Strawberry Splash (sodium fluoride paste, dentifrice) during pregnancy. Consequently, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider this lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

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

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 caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for BURTS BEES KIDS STRAWBERRY SPLASH (sodium fluoride paste, dentifrice).

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, away from extreme temperatures. It is essential to protect the product from freezing to maintain its quality. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and preserve the formulation.

Additional Clinical Information

The product is administered via the dental route. 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, immediate medical assistance or contact with a Poison Control Center is necessary. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and caregivers should supervise brushing until proper habits are established. Additionally, for children under 2 years of age, consultation with a dentist is advised.

Drug Information (PDF)

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

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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.