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Colgate Maximum Cavity Protection

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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 2020
Label revision date
March 3, 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 2020
Label revision date
March 3, 2026
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-196

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Drug Overview

Colgate® Anticavity Fluoride Toothpaste is designed to help protect your teeth against cavities. It provides maximum cavity protection, making it a reliable choice for maintaining your dental health. This toothpaste is flavored with BUBBLE FRUIT®, which can make brushing more enjoyable, especially for children.

Additionally, Colgate® Anticavity Fluoride Toothpaste is accepted by the American Dental Association (ADA), ensuring that it meets high standards for safety and effectiveness. With a net weight of 4.4 ounces (124 grams), it’s a convenient option for your daily oral care routine.

Uses

You can use this product to help protect your teeth against cavities. It works by strengthening your enamel and creating a barrier that helps prevent decay. This is especially important for maintaining good oral health and keeping your smile bright.

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 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 2 and 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 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.

By following these guidelines, you can help ensure the safe use of this product.

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. 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, so it's best to be cautious. 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 safe and get help when it comes to potential overdoses.

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 safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given the lack of information, it's advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 the ingredients could be passed into your breast milk, so caution is advised.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product. Your healthcare provider can help you make an informed decision that prioritizes both your health and your baby's well-being.

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 the product and supervise your child to minimize the risk of swallowing. If your child is under 2 years old, consult a dentist or physician before use to ensure it's safe for them.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of your age and any existing health conditions, as this can influence how the medication works for you. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the container tightly closed when not in use to maintain its integrity. Additionally, remember to discard any unused product after the expiration date to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

When using this medication, it is administered through dental means. If you are giving this to a child, it's important to supervise their brushing and rinsing to help prevent swallowing the product. Make sure to use only a pea-sized amount for effective use.

FAQ

What is Colgate® Anticavity Fluoride Toothpaste used for?

Colgate® Anticavity Fluoride Toothpaste helps protect against cavities.

What is the flavor of Colgate® Anticavity Fluoride Toothpaste?

The flavor of Colgate® Anticavity Fluoride Toothpaste is BUBBLE FRUIT®.

What age group can use Colgate® Anticavity Fluoride Toothpaste?

Adults and children 2 years of age and older can use this toothpaste.

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 2 years needs to use this toothpaste?

If a child is under 2 years old, you should ask a dentist or physician before use.

Are there any contraindications for using this toothpaste?

No contraindications are listed for Colgate® Anticavity Fluoride Toothpaste.

What should I do if more toothpaste than needed is swallowed?

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

Is there any information about using this toothpaste during pregnancy?

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

Can nursing mothers use Colgate® Anticavity Fluoride 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, protect it from freezing, and keep the container tightly closed when not in use.

Is Colgate® Anticavity Fluoride Toothpaste accepted by any dental associations?

Yes, it is accepted by the American Dental Association (ADA).

Packaging Info

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

Packaging configurations for Colgate Maximum Cavity Protection.
Details

Drug Information (PDF)

This file contains official product information for Colgate Maximum Cavity Protection, 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 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 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 intervention.

Side Effects

Patients should be advised to keep the product out of reach of children under 6 years of age. 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 at greater risk of adverse reactions from improper use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Maximum Cavity Protection (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Colgate Maximum Cavity Protection.
Details

Pediatric Use

Pediatric patients should be supervised during brushing and rinsing to minimize swallowing, using only a pea-sized amount of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or physician. For children under 2 years of age, consultation with a dentist or physician is advised prior to use.

It is important 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 should be sought immediately, or contact a Poison Control Center.

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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. 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 prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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 insert 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 configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from freezing conditions. To maintain product integrity, the container must be kept tightly closed when not in use. Additionally, any unused product should be discarded after the expiration date to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to supervise children's brushing and rinsing to minimize the risk of swallowing. Additionally, it is recommended to use only a pea-sized amount of the product during application.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Colgate Maximum Cavity Protection, 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 Maximum Cavity Protection, 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.