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Colgate Kids Unicorn Alcohol Free

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
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 2022
Label revision date
January 9, 2024
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-334
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

Colgate® Anticavity Fluoride Rinse is a mouthwash designed to help prevent dental cavities. It is alcohol-free and comes in a 500 mL bottle with a pleasant Bubble Fruit® flavor. This rinse works by strengthening your tooth enamel, protecting your teeth from cavities, and providing a thorough clean for your entire mouth.

Using this fluoride rinse can be an effective part of your oral hygiene routine, helping to maintain a healthy smile and reduce the risk of tooth decay.

Uses

You can use this product to help prevent dental cavities. It works by strengthening your teeth and making them more resistant to decay. It's important to maintain good oral hygiene alongside using this product for the best results.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To use this mouth rinse effectively, you should follow these steps. If you are an adult or a child aged 6 years and older, rinse your mouth twice a day after brushing your teeth with toothpaste. Take 10 mL (which is about 2 teaspoonfuls) 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 the mouth rinse, avoid eating or drinking for 30 minutes to allow the rinse to work effectively. If you are supervising a child under 12, make sure to teach them proper rinsing habits to prevent swallowing the rinse. For children under 6 years old, it’s best to consult a dentist or doctor before use.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care to use it as directed.

If you accidentally swallow more than what is intended for rinsing, seek medical assistance immediately or contact a Poison Control Center. Your safety is a priority, so always follow the usage instructions carefully.

Side Effects

It's important to keep this product out of reach of children. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. This ensures your safety and addresses any potential risks associated with misuse.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

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. 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 Colgate Kids Unicorn Alcohol Free sodium fluoride rinse during pregnancy, there is currently no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best practices for maintaining oral health during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this mouth rinse out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, the rinse can be used twice a day after brushing teeth. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. Make sure they do not swallow the rinse or eat or drink anything for 30 minutes after using it.

For children under 12, it's essential to teach them proper rinsing habits to reduce the risk of swallowing the rinse. Always supervise younger children until they can use the rinse safely on their own. If your child is under 6 years old, consult 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 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 regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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. In this case, there are no known interactions with other drugs or laboratory tests. However, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

Remember, even if no interactions are currently noted, your health can change, and new information may arise. Regular discussions with your provider can help you stay informed and safe.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 68 and 77°F (20 to 25°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should use this dental rinse twice a day after brushing your teeth. To use it, vigorously swish 10 mL (which is about 2 teaspoonfuls) between your teeth for 1 minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it. If you have children under 12, make sure to teach them proper rinsing habits to prevent swallowing, and supervise them until they can rinse safely on their own.

Keep this product out of reach of children. If someone accidentally swallows more than intended, seek medical help or contact a Poison Control Center immediately. For children under 6 years old, consult a dentist or doctor before use.

FAQ

What is Colgate® Anticavity Fluoride Rinse used for?

Colgate® Anticavity Fluoride Rinse aids in the prevention of dental cavities.

How should I use Colgate® Anticavity Fluoride Rinse?

Use it twice a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute and then spit it out.

Can children use Colgate® Anticavity Fluoride Rinse?

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

Are there any warnings for using this rinse?

Keep it out of reach of children. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Is there any information about using Colgate® Anticavity Fluoride Rinse during pregnancy or while nursing?

No specific information is provided regarding its use during pregnancy or lactation.

What should I do if I accidentally swallow the rinse?

If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

What is the storage requirement for Colgate® Anticavity Fluoride Rinse?

Store it at controlled room temperature between 68 – 77°F (20 – 25°C).

Packaging Info

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

Packaging configurations for Colgate Kids Unicorn Alcohol Free.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Colgate® Anticavity Fluoride Rinse is an alcohol-free oral care product specifically formulated for children. It is presented in a dosage form of a liquid rinse, with a volume of 16.9 fluid ounces (500 mL). The product features a Bubble Fruit® flavor, designed to appeal to younger users. It is essential to read the directions for proper use to ensure effective application and safety.

Uses and Indications

This drug is indicated for the prevention of dental cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) 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. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing 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 demonstrates the ability to use the rinse independently.

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

Contraindications

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

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing 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 of the situation.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not exhibit significant pharmacokinetic or pharmacodynamic interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Colgate Kids Unicorn Alcohol Free.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing.

Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended for these 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 necessary 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 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 Colgate Kids Unicorn Alcohol Free sodium fluoride rinse 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.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 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 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 medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical assistance immediately or contact a Poison Control Center for guidance. This precaution is crucial to ensure patient safety and to address any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 68 to 77°F (20 to 25°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should use the product via the dental route, rinsing twice daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for 1 minute before spitting it out. It is important not to swallow the rinse and to refrain from eating or drinking for 30 minutes following the rinse. Clinicians should instruct children under 12 years in proper rinsing techniques to minimize the risk of swallowing and supervise them as necessary until they can rinse independently.

Patient counseling should emphasize keeping the product out of reach of children. In the event of accidental ingestion of more than the recommended amount, patients should seek medical assistance or contact a Poison Control Center immediately. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Colgate Kids Unicorn Alcohol 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 Colgate Kids Unicorn Alcohol 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.