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Colgate Kids Minions Mouthwash

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
February 19, 2025
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
Marketed in the U.S.
Since 2015
Label revision date
February 19, 2025
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-727

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Drug Overview

Colgate® Kids Anticavity Fluoride Rinse is a mouthwash designed to help prevent dental cavities in children. This alcohol-free rinse comes in a 500 mL bottle and features a fun flavor called "BELLO™ BUBBLE FRUIT," making it more appealing for kids to use.

By incorporating this rinse into your child's oral hygiene routine, you can support their dental health and help protect their teeth from cavities.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of tooth decay. Regular use can be an effective way to maintain a healthy smile.

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, use the rinse twice a day after brushing your teeth with toothpaste. Measure out 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively. If you are supervising a child under 12, make sure to guide them on how to rinse properly to avoid swallowing the rinse. For children under 6 years old, it's best to consult a dentist or doctor before using this product.

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 not to swallow more than what is intended for rinsing. If you accidentally swallow more than the recommended amount, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please use this product as directed.

Side Effects

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. This precaution helps ensure safety and prevent any potential harm.

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.

While there are no specific general precautions or laboratory tests mentioned, always use this product as directed. If you have any concerns or experience unusual symptoms, it's best to consult your doctor for guidance.

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

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. The insert does not indicate whether the product is safe or poses any risks to your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

There is no specific information available about the use of Colgate Kids Minions Mouthwash for nursing mothers or during lactation (the period when a mother breastfeeds). This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this mouthwash to ensure it is safe for you and your baby. Always prioritize your health and your child's well-being when considering new products.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, you can use this product twice a day after brushing their teeth with toothpaste.

For children under 12, make sure to teach them proper rinsing habits to help prevent swallowing. Always supervise younger children until they can use the product safely on their own. If your child is under 6 years old, it's best to consult with a dentist or doctor before use.

Geriatric Use

While there is no specific information about the use of Colgate Kids Minions Mouthwash in older adults, it's always important to approach any new product with caution. If you are caring for an older adult, consider their overall health and any existing conditions before introducing new oral care products.

Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, it’s advisable to monitor for any unusual reactions or changes in oral health after use. If you have any questions or concerns, consulting with a healthcare professional can provide personalized guidance.

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 for patients with 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 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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety 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 integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

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 rinsing to allow the product to work effectively.

If you have children under 12, make sure to teach them proper rinsing habits to prevent swallowing the rinse. It's important to supervise younger children until they can rinse without help. For children under 6 years old, consult a dentist or doctor before use.

FAQ

What is Colgate® Kids Anticavity Fluoride Rinse used for?

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

What is the recommended usage for adults and children 6 years and older?

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

What should I do if more than the recommended amount is swallowed?

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

Are there any precautions for children under 6 years of age?

Yes, consult a dentist or doctor before use for children under 6 years of age.

What flavor does the rinse come in?

The product includes the flavor 'BELLO™ BUBBLE FRUIT'.

How should I store Colgate® Kids Anticavity Fluoride Rinse?

Store the rinse at a controlled room temperature of 68 – 77°F (20 – 25°C).

Is this rinse safe for pregnant or nursing women?

No specific information regarding use during pregnancy or nursing is provided in the insert.

What should I do if I need to supervise children using the rinse?

Instruct children under 12 years of age in good rinsing habits and supervise them until they can use it without assistance.

Packaging Info

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

Packaging configurations for Colgate Kids Minions Mouthwash.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Colgate® Kids Anticavity Fluoride Rinse is an alcohol-free oral care product designed for children. This rinse features a unique BELLO™ BUBBLE FRUIT® flavor, making it appealing for young users. The product is packaged in a 16.9 FL OZ (1.05 PT) bottle, containing 500 mL of the solution. It is identified by the product code P9902670. The formulation is intended to provide anticavity benefits while ensuring a safe and enjoyable experience for children. Important usage directions should be read and followed for optimal results.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following the brushing of teeth 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 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 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

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

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 for rinsing 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.

Currently, there are no additional general precautions or laboratory tests specified in the product insert. However, the emphasis on the importance of monitoring for accidental ingestion remains critical.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of proper usage and the potential risks associated with accidental ingestion.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Colgate Kids Minions Mouthwash.
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, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, the product is indicated for use twice daily following tooth brushing with toothpaste. It is essential to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing the product. 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 use Colgate Kids Minions Mouthwash; however, the prescribing information does not provide specific guidance regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when recommending this product to geriatric patients, as the absence of specific data necessitates careful consideration of individual patient factors, including overall health status and potential comorbidities. Monitoring for any adverse effects or unusual reactions is advisable when this mouthwash is used by elderly patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information regarding the use of Colgate Kids Minions Mouthwash in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment and monitoring of these patients.

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 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 the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if more than the recommended amount used for rinsing is accidentally swallowed, they should seek medical assistance or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing 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

The product is administered via the dental route, with a recommended frequency of twice daily following tooth brushing. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes post-rinsing.

Clinicians should counsel patients, particularly parents of children under 12 years, to instruct their children in proper rinsing techniques to minimize the risk of swallowing. Supervision is advised for children until they can rinse without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Colgate Kids Minions Mouthwash, 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 Minions Mouthwash, 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.