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Colgate Deep Clean 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 2015
Label revision date
December 18, 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 2015
Label revision date
December 18, 2019
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-969

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Drug Overview

Colgate® Anticavity Fluoride Toothpaste is designed to help protect your teeth against cavities. It works by penetrating between your teeth to provide a thorough clean, utilizing a micro-foaming action that enhances its effectiveness. This toothpaste comes in a refreshing Brisk Mint flavor, making your oral care routine more enjoyable while promoting dental 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.

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 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 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.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use the product as directed 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.

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 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 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 always be obvious, so it's best 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

When it comes to using Colgate Deep Clean 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 if you have any concerns or questions about its use during your pregnancy. It's always best to prioritize your health and the health of your baby by discussing any products you use with a medical professional.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that the ingredients may be passed into your breast milk, so caution is advised to ensure the safety of both you and your nursing infant. Always prioritize open communication with your healthcare provider to make informed decisions about 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. For children aged 2 to 6 years, you should only use a pea-sized amount and closely 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 to ensure safety.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

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 drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

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 tube tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

No further information is available.

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 Brisk Mint.

How should adults and children 2 years and older use this toothpaste?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

What precautions should be taken for children aged 2 to 6 years?

Children 2 to 6 years should use only a pea-sized amount of toothpaste 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 of age, you should ask a dentist or physician before use.

Are there any contraindications for using this toothpaste?

No contraindications are specified 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 regarding the use of this toothpaste during pregnancy?

No specific information regarding the use of Colgate® Anticavity Fluoride Toothpaste during pregnancy is provided.

What should nursing mothers know before using 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, protect it from freezing, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Colgate Deep Clean Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Colgate Deep Clean 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 formulated to provide effective dental care through its unique micro-foaming action, which penetrates between teeth to deliver a thorough clean. The product is presented in a brisk mint flavor, enhancing the user experience while promoting oral hygiene. Each tube contains a net weight of 6.0 ounces (170 grams) and is designed for new users seeking a deep cleaning solution.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, and 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 care.

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 warnings highlight the importance of proper usage and the potential risks associated with accidental ingestion, particularly in young children.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Colgate Deep Clean Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product and to supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is advised 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 potential 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 Deep Clean Fluoride Toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, 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 their healthcare provider for personalized guidance.

Lactation

Lactating 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.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 focus on 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 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 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 efficacy. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Colgate Deep Clean 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 Deep Clean 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.