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Willo Berry Splash Dye Free

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Active ingredient
Sodium Fluoride 1 mg/1 mL
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
September 16, 2025
Active ingredient
Sodium Fluoride 1 mg/1 mL
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 2025
Label revision date
September 16, 2025
Manufacturer
Willo 32, Inc
Registration number
M021
NDC root
84185-202

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

Drug Overview

Willo is a berry-flavored anticavity fluoride foaming toothpaste designed to help you maintain good oral health. Its primary purpose is to aid in the prevention of dental cavities, making it a helpful addition to your daily dental care routine.

Each package contains two 2 fl oz (59 ml) bottles, providing you with a convenient supply to keep your teeth healthy and strong. By using Willo regularly, you can support your efforts to protect your smile from cavities.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. You should supervise them until they can brush their teeth on their own effectively.

For children under 2 years of age, it's best to consult with a dentist or doctor before starting any dental care routine. They can provide guidance tailored to your child's needs. Remember, maintaining good oral hygiene is essential for everyone!

What to Avoid

It's important to use this product safely. Keep it out of reach of children under 6 years old and ensure they are supervised when using it. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact the Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always follow the usage instructions carefully to ensure safety.

Side Effects

It's important to keep this medication out of reach of children under 6 years old unless an adult is supervising. If a child accidentally swallows more than what is typically used for brushing their teeth, seek medical help or contact the Poison Control Center immediately.

Always be aware of the potential risks associated with medications, and ensure that they are used safely and appropriately.

Warnings and Precautions

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

Always use this medication as directed and be aware of any unusual reactions. If you experience any concerning symptoms, stop using the medication and call your doctor for guidance. 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

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old unless they are being supervised by an adult. If a 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, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor. For younger children under 6, make sure to teach them proper brushing and rinsing techniques to reduce the risk of swallowing the product, and supervise them until they can brush independently. If your child is under 2 years old, it's best to consult with a dentist or doctor 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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 your condition may affect your treatment plan.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, remember to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

The medication is administered through a dental route, meaning it is used in the mouth, typically for oral health purposes. It's important to keep this product out of reach of children under 6 years old and ensure they are supervised by an adult while using it. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Willo?

Willo is a Berry Splash Anticavity Fluoride Foaming Toothpaste that aids in the prevention of dental cavities.

Who can use Willo?

Willo is intended for adults and children 2 years of age and older. Children under 2 years should consult a dentist or doctor.

How should I use Willo?

Brush your teeth thoroughly with Willo, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What precautions should I take for children using Willo?

For children under 6 years, instruct them in good brushing and rinsing habits and supervise their use until they can do it without help.

What should I do if Willo is swallowed accidentally?

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

Are there any contraindications for using Willo?

No contraindications are listed for Willo.

Is Willo safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Willo by nursing mothers.

How should I store Willo?

Store Willo at room temperature, protect it from light, and do not freeze. Discard it after opening.

Are there any known drug interactions with Willo?

No drug interactions information is provided for Willo.

Is there any specific information regarding the use of Willo in elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

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

Packaging configurations for Willo Berry Splash Dye Free.
Details

Drug Information (PDF)

This file contains official product information for Willo Berry Splash Dye Free, 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.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age without adult supervision due to the potential risk of accidental ingestion. In the event of accidental swallowing of an amount exceeding that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age unless under adult supervision. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to educate caregivers on the importance of supervision during use to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age and to ensure that it is used under adult supervision. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

These precautions are essential to prevent serious adverse reactions that may arise 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 Willo Berry Splash Dye Free (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Willo Berry Splash Dye Free.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach without adult supervision. 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 advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize swallowing, with supervision provided until they are capable of brushing without assistance. For infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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.

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 may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care as needed. It is essential to follow established protocols for overdosage management to ensure patient safety and effective treatment.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age and to ensure that it is used only under adult supervision. It is important to emphasize the necessity of monitoring young children during use to prevent accidental ingestion.

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 the Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of the patient.

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 light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

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 and ensure it is used under adult supervision. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Willo Berry Splash Dye Free, 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 Willo Berry Splash Dye Free, 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.