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Colgate

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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 2011
Label revision date
April 9, 2019
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 2011
Label revision date
April 9, 2019
Manufacturer
Mission Hills S. A de C. V
Registration number
M021
NDC root
65954-014

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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. This toothpaste comes in a 6.0 oz (170 g) tube and features a refreshing cool mint flavor, along with a variant called Max Fresh® that includes whitening properties and breath strips for long-lasting freshness.

The key ingredient in this toothpaste is fluoride, which works to strengthen tooth enamel and prevent decay. By using Colgate® Anticavity Fluoride Toothpaste regularly, you can maintain better oral health and enjoy a brighter smile.

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, so you can feel confident in its safety for use.

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 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 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.

Always be aware of how to use this product safely to avoid any potential risks.

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 may not be obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Always prioritize your health and well-being by acting quickly in these situations.

Pregnancy Use

When it comes to using Colgate Max Fresh Cool Mint Fluoride Toothpaste during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that while the toothpaste is commonly used, you may want to consult with your healthcare provider for personalized advice, especially if you have any concerns about its ingredients or your oral health during pregnancy.

It's always best to prioritize your health and the health of your baby, so don't hesitate to reach out to your doctor or dentist if you have questions about dental care products while pregnant.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no detailed guidelines or warnings, it’s always a good idea to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the benefits and risks to ensure the safety of 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 your dentist's or physician's advice. If your child is between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of swallowing. For children under 2 years, consult with 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 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 prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it, as extreme cold can damage it. When not in use, make sure to keep the tube tightly closed to maintain its integrity and prevent contamination. Additionally, remember to discard any unused product after the expiration date to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is used in the mouth, typically for oral health purposes. 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 used for brushing, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Colgate® Anticavity Fluoride Toothpaste?

Colgate® Anticavity Fluoride Toothpaste is a dental product that helps protect against cavities. It comes in a 6.0 oz (170 g) tube with a COOL MINT flavor and features Max Fresh® with WHITENING and BREATH STRIPS.

How should I use Colgate® Anticavity Fluoride Toothpaste?

For adults and children 2 years of age and older, brush your teeth thoroughly, preferably after each meal or at least twice a day. Children 2 to 6 years should use only a pea-sized amount and be supervised while brushing.

Are there any contraindications for using this toothpaste?

No contraindications are listed for Colgate® Anticavity Fluoride Toothpaste.

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.

Is this toothpaste safe for children under 2 years?

For children under 2 years, you should ask a dentist or physician before use.

How should I store Colgate® Anticavity Fluoride Toothpaste?

Store the toothpaste at room temperature, do not freeze, and keep the tube tightly closed when not in use. Discard any unused product after the expiration date.

Are there any warnings associated with this toothpaste?

Yes, keep out of reach of children under 6 years of age, and if more than used for brushing is swallowed, seek medical help immediately.

Does Colgate® Anticavity Fluoride Toothpaste have any teratogenic effects?

No teratogenic effects are mentioned for this toothpaste.

Is there any specific information regarding use during pregnancy or lactation?

No specific information regarding use during pregnancy or lactation is provided for Colgate® Anticavity Fluoride Toothpaste.

Packaging Info

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

Packaging configurations for Colgate.
Details

Drug Information (PDF)

This file contains official product information for Colgate, 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 formulated to provide effective cavity protection while enhancing oral freshness. This product is available in a net weight of 6.0 ounces (170 grams) and features a COOL MINT flavor. It incorporates Max Fresh® technology with whitening properties and includes breath strips designed to deliver long-lasting freshness.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. This precaution is essential to ensure the safety and well-being of young children who may be at risk of serious harm from improper use.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative 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 crucial 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

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

Packaging configurations for Colgate.
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 a day, or as directed by a dentist or physician. In children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during 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.

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 Max Fresh Cool Mint Fluoride Toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential about the use of this product during pregnancy. It is recommended that pregnant patients consult with their healthcare provider for personalized guidance.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 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 this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse.

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. This precaution is crucial to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain product integrity, the tube must be kept tightly closed when not in use. Additionally, any unused product should be discarded after the expiration date to ensure safety and effectiveness.

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 used for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Colgate, 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, 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.