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Botao Kids Strawberry Flavored with Fluoride

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Active ingredient
Sodium Fluoride 0.122 g/100 mL
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
January 12, 2026
Active ingredient
Sodium Fluoride 0.122 g/100 mL
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
January 12, 2026
Manufacturer
Peer Pharm Ltd.
Registration number
M021
NDC root
69435-1405

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

Drug Overview

This medication is designed to help maintain and protect your teeth and gums, starting from the very first tooth. It plays a crucial role in promoting oral health, ensuring that your smile stays bright and healthy as you grow. By using this product, you can support your dental hygiene routine effectively.

Uses

You can use this product to help maintain and protect your teeth and gums right from the moment your first tooth appears. It's designed to support oral health for you and your family, ensuring that your smile stays bright and healthy.

Rest assured, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which are not related to fetal development) associated with this product. This makes it a safe choice for maintaining oral hygiene.

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 6 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children aged 2 to 6 years, use only a small amount of toothpaste—about the size of a pea. It's essential to supervise their brushing and rinsing to help prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child swallows more than the amount typically used for brushing, seek medical help or contact a Poison Control Center immediately. Additionally, do not use the product if the seal is broken, as this may indicate that it is not safe to use.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. If you or someone else swallows more than the amount typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Before using the product, make sure the seal is intact. If the seal is broken, do not use it, as this may indicate that the product is not safe. Always prioritize your safety and well-being when using any medication or health product.

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 can vary, 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

When it comes to using Botao Kids Strawberry Flavored Toothpaste with Fluoride during pregnancy, there is no specific information available in the product insert. This means that the manufacturer has not provided details about whether the toothpaste is safe or poses any risks to you or your developing baby.

Since there are no contraindications (conditions that would prevent use) or special precautions mentioned, it’s always a good idea to consult with your healthcare provider if you have any concerns about using this product while pregnant. They can offer personalized advice based on your individual health needs.

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. 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 6 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, as recommended by a dentist or physician. For younger children aged 2 to 6, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, consult a dentist or physician 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 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, and there are no special monitoring or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you notice that the seal has been broken after opening, please discard the product to ensure your safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

The medication is administered through a dental route, meaning it is given directly in or around the mouth during dental procedures. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market.

FAQ

What is the purpose of this product?

This product helps to maintain and protect teeth and gums from the very first tooth.

How should adults and children 6 years of age and older use this product?

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

What is the recommended usage for children aged 2 to 6 years?

Use only a pea-sized amount and supervise the child's brushing and rinsing to minimize swallowing.

What should I do if a child under 2 years needs to use this product?

Ask a dentist or physician for guidance.

Are there any warnings associated with this product?

Keep out of reach of children under 6 years of age. If more than the amount used for brushing is swallowed, get medical help or contact a Poison Control Center right away. Do not use if the seal is broken.

Is this product safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, and no contraindications are mentioned.

Can nursing mothers use this product?

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

How should this product be stored?

Store 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 Botao Kids Strawberry Flavored with Fluoride (botao kids strawberry flavored toothpaste with fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Botao Kids Strawberry Flavored with Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Botao Kids Strawberry Flavored with Fluoride, 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 maintenance and protection of teeth and gums from the emergence of the very first tooth.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 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 physician.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of toothpaste. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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. In the event that more than the recommended amount used for brushing is swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additionally, the product should not be used if the seal is broken, as this may indicate potential contamination or compromise of the product's integrity. Ensuring the seal is intact prior to use is essential for maintaining safety and efficacy.

Side Effects

Patients should be aware of the following warnings 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 amount typically used for brushing is swallowed, patients are advised to seek medical help or contact a Poison Control Center immediately. Additionally, the product should not be used if the seal is broken, as this may indicate potential contamination or compromised safety.

These precautions are essential to ensure the safe use of the product and to mitigate any risks associated with improper handling or ingestion.

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 warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Botao Kids Strawberry Flavored with Fluoride (botao kids strawberry flavored toothpaste with fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Botao Kids Strawberry Flavored with Fluoride.
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 used for brushing is swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

For children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing.

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

Geriatric Use

There is no specific information available 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 Botao Kids Strawberry Flavored Toothpaste with Fluoride in pregnant patients. The product insert does not provide any statements indicating whether the product is contraindicated during pregnancy, nor does it outline any potential risks to the fetus or special precautions for use in this population. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the benefits against any potential risks.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of 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 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 assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and, if indicated, decontamination measures.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will facilitate optimal patient outcomes.

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 available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

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, the tube must be kept tightly closed when not in use. Additionally, if the seal is broken upon opening, the product should be discarded to prevent any potential contamination or degradation.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Botao Kids Strawberry Flavored with Fluoride, 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 Botao Kids Strawberry Flavored with Fluoride, 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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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.