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Colgate Kids

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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)
Marketed in the U.S.
Since 2016
Label revision date
March 12, 2026
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
Marketed in the U.S.
Since 2016
Label revision date
March 12, 2026
Manufacturer
Mission Hills, S. A. de C. V.
Registration number
M021
NDC root
65954-065

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 Toothpaste is a dental care product designed to help protect your teeth against cavities. It contains fluoride, which is a key ingredient that strengthens tooth enamel and helps prevent decay. This toothpaste comes in a pleasant Bubble Fruit® flavor, making brushing your teeth a more enjoyable experience.

Additionally, Colgate® Anticavity Fluoride Toothpaste is recognized by the American Dental Association® (ADA), ensuring that it meets high standards for safety and effectiveness. The toothpaste is packaged in a recyclable tube, reflecting a commitment to environmental sustainability.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

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 to 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 keep this product out of the reach of children under 6 years old to ensure their safety. 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 mindful of any potential risks associated with misuse. Your safety is a priority, so please follow these guidelines carefully.

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.

Please be aware of these precautions to ensure safety while using the product.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old 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. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. 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 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

There is currently no specific information available about the use of Colgate Kids Mild Bubble Fruit Flavor toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using this product during pregnancy. They can offer personalized advice based on your individual health needs.

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 it can be passed into breast milk, so caution is recommended.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits before making a decision. Your healthcare provider can help you understand these factors and guide you in making the best choice for you and 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 the advice of a dentist or physician. Use only a pea-sized amount of the product and supervise your child while they brush and rinse 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 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.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations available for how your treatment may need to be altered 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 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 ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 best performance of your product, store it at room temperature and avoid freezing it. When not in use, make sure to keep the tube tightly closed to maintain its integrity. If you open the tube and do not use the contents within a specified time frame, it’s important to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth, typically for oral care. When using this product, it's important to keep it 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, use only a pea-sized amount 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.

FAQ

What is Colgate® Anticavity Fluoride Toothpaste used for?

Colgate® Anticavity Fluoride Toothpaste helps protect against cavities.

What age group can use this toothpaste?

This toothpaste is suitable for adults and children 2 years of age and older.

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 a child under 6 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 on the use of this toothpaste during pregnancy?

No specific information regarding the use of this toothpaste during pregnancy is provided.

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.

How should I store Colgate® Anticavity Fluoride Toothpaste?

Store the toothpaste at room temperature, keep the tube tightly closed when not in use, and do not freeze.

Is there any risk of dependence or abuse with this toothpaste?

No risks of dependence or abuse are specified for this toothpaste.

What flavor does this toothpaste have?

Colgate® Anticavity Fluoride Toothpaste has a Bubble Fruit® flavor.

Is the tube recyclable?

Yes, the tube of Colgate® Anticavity Fluoride Toothpaste is recyclable.

Packaging Info

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

Packaging configurations for Colgate Kids.
Details

Drug Information (PDF)

This file contains official product information for Colgate Kids, 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 protection against cavities.

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

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, if more than the recommended amount for brushing is swallowed, seek medical assistance or contact a Poison Control Center immediately.

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 used 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 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

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 Colgate Kids (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Colgate Kids.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this 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 a day, or as directed by a dentist or physician. A pea-sized amount of the product should be used, and supervision during brushing and rinsing is essential to minimize the risk of swallowing.

For infants and children under 2 years of age, consultation with a dentist or physician is necessary before 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 Colgate Kids Mild Bubble Fruit Flavor toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise clinical judgment when recommending this product to women of childbearing potential. It is advisable to consider the overall context of oral care during pregnancy and to discuss any concerns with patients.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

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. Symptoms may vary depending on the specific substance involved, and monitoring for any unusual reactions is advised.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care measures. It is essential to follow established protocols for overdosage management, which may involve decontamination, symptomatic treatment, and further medical evaluation as necessary.

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 available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients 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, medical assistance or contact with a Poison Control Center should be sought immediately. It is recommended to use only a pea-sized amount and to supervise children's brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Colgate Kids, 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, 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

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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.