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Hello Dragon Dazzle

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Active ingredient
Sodium Fluoride 1.5 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
May 28, 2025
Active ingredient
Sodium Fluoride 1.5 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
May 28, 2025
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-679

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

Drug Overview

Friendly Hello Dragon Dazzle Fluoride Toothpaste is a specially formulated fluoride toothpaste designed for children ages 2 and older. This toothpaste helps protect against cavities, prevents new cavities from forming, and strengthens tooth enamel, making it an excellent choice for maintaining your child's dental health.

With a delightful blue raspberry natural flavor, this toothpaste not only tastes magical but also polishes and brightens teeth. It is free from artificial sweeteners, dyes, and sodium lauryl sulfate (SLS), ensuring a gentle and enjoyable brushing experience for your little ones.

Uses

You can use this product to help protect your teeth against cavities and prevent them from forming in the first place. It also works to polish and brighten your smile, giving your teeth a cleaner, more radiant appearance. Additionally, this product strengthens your enamel, which is the hard outer layer of your teeth, helping to keep them healthy and resilient.

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 between 2 and 6 years old, make sure to use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

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

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 be aware of how you use this product to ensure safety for yourself and others.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age 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 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. Always prioritize your health and well-being by acting quickly in these situations.

Pregnancy Use

When considering the use of Hello Dragon Dazzle Fluoride during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is advisable to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Your healthcare provider can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Hello Dragon Dazzle Fluoride does not provide specific information about its use in nursing mothers or any considerations related to lactation. This means there are no established guidelines or data regarding how this product may affect breast milk or your nursing infant.

As always, it's best to consult with your healthcare provider for personalized advice and to discuss any concerns you may have about using this product while breastfeeding. They can help you make informed decisions that prioritize your health and the well-being of your baby.

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 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, following your dentist's or physician's advice. For children between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of 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 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 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 discuss any concerns you may have about taking this medication with your liver condition. They can help 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. It's important to protect it from excessive heat, as high temperatures can affect its quality. Please remember not to freeze the product, as this can also compromise its effectiveness. If you open the tube and do not use it within a specified time, be sure to discard it to maintain safety and efficacy.

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 works or its specific use, be sure to consult your healthcare provider.

FAQ

What is friendly hello dragon dazzle fluoride toothpaste?

It is a fluoride toothpaste designed for kids ages 2 and older that helps protect against cavities.

What are the key benefits of using this toothpaste?

This toothpaste helps protect against cavities, prevents cavities, polishes and brightens teeth, and strengthens enamel.

What flavor does this toothpaste have?

It has a blue raspberry natural flavor that tastes magical.

How should children aged 2 to 6 use this toothpaste?

Children aged 2 to 6 should use only a pea-sized amount and should be supervised while brushing and rinsing to minimize swallowing.

What should I do if my child accidentally swallows more toothpaste than used for brushing?

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

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

The drug insert does not provide specific information regarding use during pregnancy or lactation.

How should I store this toothpaste?

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

Are there any contraindications for using this toothpaste?

No specific contraindications are listed for friendly hello dragon dazzle fluoride toothpaste.

Packaging Info

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

Packaging configurations for Hello Dragon Dazzle.
Details

Drug Information (PDF)

This file contains official product information for Hello Dragon Dazzle, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Dragon Dazzle Fluoride Toothpaste is formulated for children aged 2 years and older. This toothpaste features a blue raspberry natural flavor and is designed to prevent cavities while polishing and brightening teeth. It strengthens enamel and is free from artificial sweeteners, dyes, and sodium lauryl sulfate (SLS). The product is presented in a net weight of 4.2 ounces (119 grams).

Uses and Indications

This drug is indicated for the prevention of dental cavities. It helps protect against the formation of cavities, while also polishing and brightening teeth. Additionally, it strengthens enamel, contributing to overall dental health.

There are no known 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, 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 the product. 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

Use is contraindicated in children under 6 years of age 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 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 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

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Hello Dragon Dazzle.
Details

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is advised 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 aged 2 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 required during brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is advised before 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 specific information regarding the use of Hello Dragon Dazzle Fluoride in pregnant patients, including safety concerns, dosage modifications, or special precautions during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when managing pregnant patients who may require fluoride treatment.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Hello Dragon Dazzle Fluoride. Therefore, healthcare professionals should exercise caution when considering the use of this product in lactating mothers. The potential effects on breastfed infants are not documented, and further research may be necessary to establish safety and efficacy in this population.

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. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

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 excessive heat sources. To maintain the product's quality, the tube must be kept tightly closed when not in use. Freezing the product is not recommended, as it may compromise its effectiveness. Additionally, it is advised to discard the product after opening if it is not used within a specified time frame.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Hello Dragon Dazzle, 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 Hello Dragon Dazzle, 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.