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Colgate Enamel Health Mouthwash

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
December 6, 2023
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Rinse
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 6, 2023
Manufacturer
Colgate-Palmolive Company
Registration number
M021
NDC root
35000-728

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Drug Overview

Colgate® Anticavity Fluoride Mouthwash is an alcohol-free mouthwash designed to help prevent dental cavities. It works by replenishing natural calcium back into your tooth enamel, reversing softening of the enamel, and strengthening areas that brushing might miss. Additionally, it freshens your breath, making it a great addition to your oral hygiene routine.

This mouthwash features Enamel Health™, emphasizing its role in maintaining strong and healthy enamel, which is crucial for overall dental health. It's available in a convenient 1-liter bottle, ensuring you have enough for regular use.

Uses

You can use this product to help prevent dental cavities. It works by strengthening your teeth and making them more resistant to decay. It's important to maintain good oral hygiene alongside using this product for the best results.

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 use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, rinse twice a day after brushing your teeth with toothpaste. Take 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively. If you're helping children under 12, make sure to teach them how to rinse properly to avoid swallowing the rinse, and supervise them until they can do it on their own. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be cautious when using this product. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. This ensures your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

It's important to keep this product out of reach of children. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately.

Being aware of these warnings can help ensure safe use. Always follow the recommended guidelines to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of the product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but being aware of any unusual symptoms is crucial.

Always err on the side of caution—if you suspect an overdose, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

There is currently no specific information available regarding the use of Colgate Enamel Health Mouthwash 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 before using any new products, including mouthwash, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this mouth rinse out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, the rinse can be used twice a day after brushing teeth. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. Make sure they do not swallow the rinse and avoid eating or drinking for 30 minutes after using it. Children under 12 should be guided in proper rinsing techniques to help prevent swallowing, and you should supervise them until they can rinse independently.

For children younger than 6 years, it's best to consult a dentist or doctor before using this product.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 68 and 77°F (20 to 25°C). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

The medication is administered through a dental route, meaning it is used in dental settings. If you are caring for children under 12 years old, it's important to teach them proper rinsing habits to help prevent swallowing the medication. Additionally, you should supervise them until they are able to use the medication safely on their own.

FAQ

What is Colgate® Anticavity Fluoride Mouthwash?

Colgate® Anticavity Fluoride Mouthwash is an alcohol-free mouthwash that helps prevent dental cavities.

How does this mouthwash work?

It helps replenish natural calcium back into enamel, reverses enamel softening, strengthens enamel, and freshens breath.

Who can use this mouthwash?

Adults and children 6 years of age and older can use it. Children under 6 years should consult a dentist or doctor.

How should I use Colgate® Anticavity Fluoride Mouthwash?

Use twice a day after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) for 1 minute and then spit it out. Do not swallow the rinse.

Are there any warnings for this mouthwash?

Keep out of reach of children. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center.

Is there any information about using this mouthwash during pregnancy or while nursing?

No specific warnings or considerations are mentioned regarding use during pregnancy or lactation.

What should I do if I accidentally swallow the mouthwash?

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center immediately.

What is the recommended storage condition for this mouthwash?

Store at controlled room temperature between 68 – 77° F (20 – 25°C).

Packaging Info

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

Packaging configurations for Colgate Enamel Health Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Colgate Enamel Health Mouthwash, 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 prevention of dental cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child demonstrates the ability to use the rinse independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing 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 of the situation.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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

Packaging configurations for Colgate Enamel Health Mouthwash.
Details

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. They should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is crucial that they do not swallow the rinse and refrain from eating or drinking for 30 minutes post-rinsing. Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing, and supervision is recommended until they can use the product independently.

For children under 6 years of age, consultation with a dentist or doctor is necessary prior to use.

Geriatric Use

There is no specific information available 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 Enamel Health Mouthwash during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

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 intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 provided in the insert for Colgate Enamel Health Mouthwash (sodium fluoride rinse).

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and addressing potential risks associated with misuse.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 68 to 77°F (20 to 25°C) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's integrity.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize the risk of swallowing. Additionally, it is important for caregivers to supervise children during use until they are capable of using the product independently.

Drug Information (PDF)

This file contains official product information for Colgate Enamel Health Mouthwash, 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 Enamel Health Mouthwash, 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.