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Hello Unicorn Sparkle

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Active ingredient
Sodium Fluoride 1.1 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
May 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 1.1 mg/1 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
May 13, 2025
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-686
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Unicorn sparkle fluoride toothpaste is a special toothpaste designed for kids ages 2 and older. It contains fluoride, which helps protect against and prevent cavities, while also polishing and brightening teeth. Additionally, it strengthens tooth enamel, making it a great choice for maintaining your child's dental health.

This toothpaste comes in a fun bubble gum natural flavor that kids will love, making brushing a more enjoyable experience. With no artificial sweeteners, dyes, or sodium lauryl sulfate (SLS), you can feel good about what your child is using to keep their teeth clean and healthy.

Uses

Using this product can 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 you a more radiant appearance. Additionally, it 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 them 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 use it as directed 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 minimize any risks associated with accidental ingestion. Your safety is a priority, so please take these precautions seriously.

Warnings and Precautions

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

In case of accidental swallowing of a larger amount, getting emergency medical assistance is crucial. Always prioritize safety and act quickly if such an incident occurs. If you have any concerns or questions about your use of this product, don't hesitate to reach out to your doctor for guidance.

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 considering the use of Hello Unicorn Sparkle (sodium fluoride gel, dentifrice) 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 effects of this product on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any new products, including dental care items like this gel. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the product may pass into your breast milk, so caution is recommended. Since the effects on your nursing infant have not been thoroughly studied, it's essential to weigh the potential risks against the benefits before making a decision.

Pediatric Use

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 aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician. For kids aged 2 to 6 years, 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 issues, 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 the medication may apply to you without any special considerations related to renal impairment (kidney problems).

However, always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance tailored to your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this product by brushing your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or physician advises otherwise. For children aged 2 to 6 years, use only a pea-sized amount and supervise their brushing and rinsing to help prevent swallowing. If your child is under 2 years old, consult a dentist or physician for guidance on use.

FAQ

What is unicorn sparkle fluoride toothpaste?

Unicorn sparkle fluoride toothpaste is a fluoride toothpaste designed for kids ages 2 and older, helping to 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 bubble gum 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 used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Is there any information about using this toothpaste during pregnancy?

No specific information regarding the use of this toothpaste during pregnancy is provided; consult a healthcare professional for advice.

Can nursing mothers use this toothpaste?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What is the recommended storage for this toothpaste?

Store the toothpaste at room temperature, protect it from light, and do not freeze.

What is the net weight of the toothpaste?

The net weight of unicorn sparkle fluoride toothpaste is 4.2 ounces (119 grams).

Packaging Info

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

Packaging configurations for Hello Unicorn Sparkle.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

friendly® hello® unicorn sparkle fluoride toothpaste is formulated for children ages 2 and older. This toothpaste features a bubble gum natural flavor that is designed to appeal to young users while effectively preventing cavities. It polishes and brightens teeth, contributing to the overall strength of enamel. The product is characterized by its magical taste and is free from artificial sweeteners, dyes, and sodium lauryl sulfate (SLS). Each tube contains a net weight of 4.2 ounces (119 grams) and is not tested on unicorns.

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities) and is effective in protecting against the formation of cavities. Additionally, it aids in polishing and brightening teeth while strengthening enamel.

There are no noted 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 risk of accidental ingestion. In the event of accidental swallowing of an amount greater than 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. 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 instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

In cases of accidental ingestion exceeding the recommended dosage, it is crucial for individuals to stop using the product and consult a healthcare provider for further guidance.

No specific general precautions or laboratory tests have been identified; however, healthcare professionals should remain vigilant and monitor for any adverse effects or complications that may arise from the use of this product.

Side Effects

Patients should be 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, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These warnings highlight the importance of proper usage and supervision to prevent potential adverse reactions associated with accidental ingestion, particularly in young children.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Unicorn Sparkle (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hello Unicorn Sparkle.
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, 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 physician. Children aged 2 to 6 years should use only a pea-sized amount of the product, 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 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 Hello Unicorn Sparkle (sodium fluoride gel, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 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 of overdosage should focus on supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage, ensuring that the patient receives appropriate evaluation and care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and addressing any potential health concerns promptly.

Storage and Handling

The product is supplied in packaging that includes 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 ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. For adults and 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 physician. For children aged 2 to 6 years, only a pea-sized amount should be used, and brushing and rinsing should be supervised to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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