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Hello Unicorn Splash

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Active ingredient
Sodium Fluoride 0.02 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
January 22, 2026
Active ingredient
Sodium Fluoride 0.02 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
January 22, 2026
Manufacturer
Accupac LLC
Registration number
M021
NDC root
44038-0687

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Drug Overview

Hello Unicorn Splash is a fun and flavorful anticavity fluoride rinse designed to help you maintain good oral health. This rinse aids in the prevention of dental cavities and strengthens your teeth, making it a great addition to your daily dental care routine. With a delightful bubble gum natural flavor and no alcohol, it’s suitable for both kids and adults looking to keep their smiles bright and healthy.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which are small holes that can form in your teeth due to decay. By using this product regularly, you can effectively prevent cavities and strengthen your teeth, making them more resistant to damage. Taking care of your dental health is important, and this product can be a helpful part of your routine.

Dosage and Administration

After brushing your teeth, you can use this mouth rinse once a day. For adults and children aged 6 years and older, take 10 mL (which is about 2 teaspoons) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're helping a child under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise younger children until they can use the rinse on their own safely. For children under 6 years old, it's best to consult with a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for rinsing, 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.

Always use this product as directed and be mindful of the amount you use. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further advice. Your health and safety are the top priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. Acting quickly can help ensure your safety.

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 know that the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are also no recommended dosage modifications for pregnant individuals, and no special precautions are mentioned regarding its use in this context.

As always, it's best to consult with your healthcare provider about any medications you are considering or currently taking 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 the use of this product while nursing. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety and effectiveness. For children aged 6 years and older, you can use it once a day after brushing their teeth. However, if your child is under 12, make sure to teach them proper rinsing habits to help prevent swallowing the product. It's also a good idea to supervise younger children until they can use it independently.

For children under 6 years old, it's best to consult with a dentist or doctor before use. This ensures that you are making the right choice for your child's dental care.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, don’t hesitate to ask your doctor or pharmacist for more information. They can provide guidance tailored to individual health situations.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 requirements 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 safety and effectiveness of your product, store it at room temperature. It's important to check the cap before use; do not use the product if the printed band around the cap is broken or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Hello Unicorn Splash?

Hello Unicorn Splash is an anticavity fluoride rinse that helps prevent dental cavities and strengthens teeth.

How should I use Hello Unicorn Splash?

Use Hello Unicorn Splash once a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoons) of the rinse between your teeth for 1 minute and then spit it out.

Can children use Hello Unicorn Splash?

Yes, children 6 years of age and older can use it, but those under 12 should be instructed in good rinsing habits and supervised as necessary. Consult a dentist or doctor for children under 6.

What should I do if I accidentally swallow more than the recommended amount?

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

Are there any contraindications for Hello Unicorn Splash?

No contraindications are listed for Hello Unicorn Splash.

Is Hello Unicorn Splash safe to use during pregnancy?

The provided information does not specify safety concerns or dosage modifications for use during pregnancy.

Can nursing mothers use Hello Unicorn Splash?

There are no specific warnings or recommendations regarding the use of Hello Unicorn Splash in nursing mothers.

How should I store Hello Unicorn Splash?

Store Hello Unicorn Splash at room temperature and do not use it if the printed band around the cap is broken or missing.

Packaging Info

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

Packaging configurations for Hello Unicorn Splash.
Details

Drug Information (PDF)

This file contains official product information for Hello Unicorn Splash, 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 prevention of dental cavities. It aids in the prevention of cavities and contributes to the strengthening of teeth.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoons) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy. For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of performing the rinsing procedure independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no contraindications listed for this product. However, it is important to note that if more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event that an excessive amount of the product, beyond what is intended for rinsing, is accidentally ingested, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is essential to ensure the safety and well-being of the patient.

Healthcare professionals are advised to educate patients on the proper use of the product to minimize the risk of accidental ingestion. Regular monitoring and patient education can significantly enhance safety and prevent adverse events associated with misuse.

Side Effects

Patients should be aware that if more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

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 Hello Unicorn Splash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hello Unicorn Splash.
Details

Pediatric Use

Pediatric patients aged 6 years and older are advised to use the product once daily after brushing their teeth with toothpaste. For children under 12 years of age, it is important to instruct them in proper rinsing habits to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes a printed band around the cap. It is essential to inspect this band prior to use; the product should not be utilized if the band is broken or missing.

Storage conditions require that the product be kept at room temperature. Proper handling and storage are crucial to ensure the integrity and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hello Unicorn Splash, 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 Unicorn Splash, 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.