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Colgate Junior Mixed Kids Bubble Fruit Fluoride

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Active ingredient
Sodium Fluoride 1.1 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
April 18, 2019
Active ingredient
Sodium Fluoride 1.1 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
April 18, 2019
Manufacturer
Mission Hills S. A de C. V
Registration number
M021
NDC root
65954-607

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Drug Overview

Colgate® Anticavity Fluoride Toothpaste is a specially formulated toothpaste designed to help protect against cavities. It is clinically proven to fight cavities while being safe for your enamel (the hard, protective layer of your teeth). This toothpaste is particularly appealing to children, featuring a fun Bubble Fruit® flavor that encourages good oral hygiene habits.

Accepted by the American Dental Association (ADA), this toothpaste provides an effective way to maintain your dental health and keep your smile bright. With regular use, it can help ensure that you and your family enjoy strong, healthy teeth.

Uses

This product is designed to help protect your teeth against cavities and actively fights against them. It has been clinically proven to be effective, ensuring that your dental enamel remains safe while using it. By incorporating this into your dental care routine, you can take a proactive step towards maintaining your oral health.

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 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.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, 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. This ensures their safety and addresses any potential risks quickly.

Warnings and Precautions

It's important to keep this product out of the 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 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 immediately obvious, but it’s always better to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Remember, your well-being is the top priority.

Pregnancy Use

There is currently no specific information available about the use of Colgate Junior Mixed Kids Bubble Fruit Fluoride Toothpaste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider about any products you plan to use, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of Colgate Junior Mixed Kids Bubble Fruit Fluoride Toothpaste for nursing mothers or during lactation (the period when a mother breastfeeds her baby). This means that if you are breastfeeding, you may want to consult your healthcare provider for personalized advice regarding the use of this toothpaste and any potential effects it may have on you or your nursing infant. It's always best to ensure that any products you use are safe for both 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.

When brushing, use only a pea-sized amount of toothpaste and supervise children aged 2 to 6 to prevent swallowing. If your child is under 2 years old, consult a dentist or physician for guidance on dental care.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions that often apply to elderly patients are not detailed in the insert.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before starting this medication. They can provide personalized advice and ensure that it is safe and appropriate for your specific health needs.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 your treatment, discussing your full medical history and any other medications is crucial. This ensures that your healthcare provider can give you the best advice tailored to your needs and help avoid any potential issues. Always feel free to ask questions and share any concerns you might have.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. It's important to avoid freezing the product, as this can affect its effectiveness. If you open the tube and do not use the contents within a certain period, be sure to discard it to maintain safety and quality. 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 and is clinically proven to be enamel safe.

What age group can use this toothpaste?

This toothpaste is suitable for adults and children 2 years of age and older. For children 2 to 6 years, use only a pea-sized amount and supervise their brushing.

Are there any teratogenic effects associated with this toothpaste?

No teratogenic effects are mentioned for Colgate® Anticavity Fluoride Toothpaste.

What should I do if my 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.

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 specific information regarding the use of this toothpaste during pregnancy or nursing?

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

What are the instructions for brushing with this toothpaste?

For adults and children 2 years and older, brush teeth thoroughly at least twice a day or as directed by a dentist. Children under 2 years should consult a dentist or physician.

Packaging Info

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

Packaging configurations for Colgate Junior Mixed Kids Bubble Fruit Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Colgate Junior Mixed Kids Bubble Fruit Fluoride, 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 and the treatment of existing cavities. It has been clinically proven to be effective in fighting cavities while being safe for enamel.

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 necessary 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, or the individual should contact a Poison Control Center without delay.

Healthcare professionals are advised to educate caregivers on the importance of proper storage and usage to mitigate the risk of accidental ingestion in young children.

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 are no known interactions with laboratory tests. As such, 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 Mixed Kids Bubble Fruit Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Colgate Junior Mixed Kids Bubble Fruit Fluoride.
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. A pea-sized amount of the product should be used, and children aged 2 to 6 years should be supervised 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

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 Junior Mixed Kids Bubble Fruit Fluoride Toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the absence 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 Colgate Junior Mixed Kids 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 on the use of this product.

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 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 symptoms of overdosage may vary, and prompt evaluation is necessary to determine the appropriate management strategy. The management of overdosage will depend on the specific circumstances and the amount ingested.

In all cases of suspected overdosage, it is essential to monitor the patient closely and provide supportive care as needed.

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.

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.

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. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations.

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, away from extreme temperatures. The tube must be kept tightly closed when not in use to prevent contamination and maintain product stability. It is important to avoid freezing the product, as this may compromise its quality. Additionally, any unused product should be discarded after opening if it is not utilized within a specified period.

Additional Clinical Information

The product is administered via the dental route. 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, immediate medical assistance or contact with a Poison Control Center is necessary. 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 Junior Mixed Kids 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 Mixed Kids 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.

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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.