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Colgate Junior Kids Batman Mild Bubble Fruit Fluoride

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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 2018
Label revision date
July 2, 2018
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 2018
Label revision date
July 2, 2018
Manufacturer
Mission Hills S. A de C. V
Registration number
M021
NDC root
65954-585

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Drug Overview

Colgate® Anticavity Fluoride Toothpaste is a clinically proven toothpaste designed to protect your teeth from cavities and strengthen enamel. It contains fluoride, which helps to prevent tooth decay by making your teeth more resistant to acid attacks from plaque bacteria and sugars in the mouth.

This toothpaste is accepted by the American Dental Association (ADA), ensuring that it meets high standards for safety and effectiveness. With a mild BUBBLE FRUIT® flavor, it offers a pleasant brushing experience while helping you maintain good oral health.

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 (which refers to effects that do not cause harm during pregnancy) 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 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 the ages of 2 and 6, 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.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always follow the usage instructions carefully 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 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 and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for further guidance. 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 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

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of Colgate Junior Kids Batman Mild Bubble Fruit Fluoride Toothpaste during nursing. This means that the effects on breast milk or your nursing infant have not been studied or documented.

As always, if you have concerns about using any products while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 what is needed for brushing, seek medical help or contact a Poison Control Center immediately.

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, it's best to consult with a dentist or physician before use.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 is safe and effective for your specific condition. They can help you understand how your kidney health may affect your medication and what steps to take for your safety.

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 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 monitor your condition and make any necessary adjustments to your treatment plan.

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.

By discussing your full medical history and any treatments, you can help prevent potential issues and ensure that your healthcare provider can monitor your health effectively.

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 product but do not use it within a specified time frame, be sure 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 dental use. If you have children, it's important to keep this product out of reach of those under 6 years old. For children aged 2 to 6, use only a pea-sized amount and supervise their brushing and rinsing to help prevent swallowing. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center immediately. For children under 2 years, consult a dentist or physician before use.

FAQ

What is Colgate® Anticavity Fluoride Toothpaste?

Colgate® Anticavity Fluoride Toothpaste is a clinically proven toothpaste that helps protect against cavities and enamel erosion.

Is Colgate® Anticavity Fluoride Toothpaste safe for children?

Yes, it is safe for children 2 years of age and older. For children 2 to 6 years, use only a pea-sized amount and supervise their brushing.

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.

Are there any contraindications for using this toothpaste?

No contraindications are listed for Colgate® Anticavity Fluoride Toothpaste.

Can I use Colgate® Anticavity Fluoride Toothpaste during pregnancy?

The insert does not provide specific information regarding the use of this toothpaste during pregnancy.

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.

What flavor does Colgate® Anticavity Fluoride Toothpaste have?

It has a mild BUBBLE FRUIT® flavor.

Is there any information about drug interactions with Colgate® Anticavity Fluoride Toothpaste?

No drug interactions or laboratory test interactions are found for this toothpaste.

Packaging Info

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

Packaging configurations for Colgate Junior Kids Batman Mild Bubble Fruit Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Colgate Junior Kids Batman Mild Bubble Fruit Fluoride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Colgate® Anticavity Fluoride Toothpaste is a clinically proven formulation designed to provide cavity and enamel protection. This toothpaste is accepted by the American Dental Association (ADA), ensuring its efficacy and safety for dental health. It is presented in a net weight of 4.6 ounces (130 grams) and features a mild Bubble Fruit® flavor.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no 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 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 used 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 is no information available regarding interactions between this drug and laboratory tests. 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 Junior Kids Batman Mild Bubble Fruit Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Colgate Junior Kids Batman Mild Bubble Fruit Fluoride.
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 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 infants and children under 2 years, consultation with a dentist or physician is necessary 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 information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no information available regarding the use of Colgate Junior Kids Batman Mild Bubble Fruit Fluoride Toothpaste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers.

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 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 recommended amount 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 related to the specific substance involved is essential, and appropriate management procedures should be initiated based on clinical judgment and established protocols.

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 available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the 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. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. 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 utilized 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, patients should seek medical assistance or contact a Poison Control Center immediately. For children aged 2 to 6 years, it is recommended to use only a pea-sized amount and to supervise the child's brushing and rinsing to minimize swallowing. For children under 2 years, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Colgate Junior Kids Batman Mild Bubble Fruit Fluoride, 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 Junior Kids Batman Mild Bubble Fruit Fluoride, 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.