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Act Total Care Anticavity Fluoride Icy Clean Mint

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Active ingredient
Sodium Fluoride 0.09 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2009
Label revision date
October 20, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.09 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2009
Label revision date
October 20, 2023
Manufacturer
Chattem, Inc.
Registration number
M021
NDC root
41167-0966
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

ACT Total Care Anticavity Fluoride Mouthwash is a dentist-recommended mouthwash designed to help prevent dental cavities. It contains sodium fluoride (0.02%), which works to strengthen tooth enamel and protect against decay. This mouthwash comes in a refreshing Icy Clean Mint flavor and is available in a 33.8 fl oz (1 L) bottle, making it a convenient addition to your oral care routine.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

If you are an adult or a child aged 6 years and older, you should use this mouth rinse twice a day after brushing your teeth with toothpaste. Start by removing the cap and pouring 10 milliliters (mL) of the rinse, making sure not to fill above the 10 mL mark indicated on the inside of the cap. Vigorously swish the rinse between your teeth for one minute, then spit it out. It’s important not to swallow the rinse, and you should avoid eating or drinking for 30 minutes after using it.

For children under 12 years old, make sure to teach them proper rinsing habits to help prevent swallowing the rinse. You should supervise younger children until they are able to use the rinse without assistance. If your child is under 6 years old, it’s best to consult a dentist or doctor before using this product.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

If you accidentally swallow more of this product than intended for rinsing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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 immediately or contact a Poison Control Center.

There are no specific general precautions or laboratory tests mentioned, but always be cautious with any medication or product you use. If you have any concerns or experience unusual symptoms, don't hesitate to reach out to your healthcare provider for guidance.

Overdose

If you accidentally swallow more of this 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.

In case of an overdose, do not wait for symptoms to appear. Prompt action can make a significant difference in your health. Always prioritize your safety and well-being by reaching out for professional assistance right away.

Pregnancy Use

When considering the use of ACT Total Care Anticavity Fluoride Mouthwash during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this mouthwash while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any new products, including mouthwash. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations 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 about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, the recommended use is twice a day after brushing their teeth with toothpaste.

For children under 12, make sure to teach them proper rinsing habits to help reduce the chance of swallowing the product. Always supervise younger children until they can use it safely on their own. If your child is under 6 years old, please consult a dentist or doctor 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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice. They can help determine the best approach to medication management, considering any unique health needs or conditions that may be present. Always prioritize open communication with healthcare providers 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 health needs. They can help determine the best approach for managing your condition while considering your kidney health.

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 detailed guidelines available for how the medication may affect you or how your liver health might influence the treatment.

Before starting any new medication, it's essential to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that your liver health is taken into account. Always keep your doctor informed about any changes in your health or concerns you may have.

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 lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the safety seal before use; do not use the product if the seal is broken or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product topically, applying it twice a day after brushing your teeth. It's important to keep it 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. Make sure to teach children under 12 about good rinsing habits to reduce the risk of swallowing, and supervise them until they can rinse without help. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

FAQ

What is ACT Total Care Anticavity Fluoride Mouthwash?

ACT Total Care Anticavity Fluoride Mouthwash is a dentist-recommended mouthwash that contains Sodium Fluoride 0.02% and is designed to aid in the prevention of dental cavities.

How should I use ACT Total Care Anticavity Fluoride Mouthwash?

You should use it twice a day after brushing your teeth. Pour 10 milliliters into the cap, swish it between your teeth for 1 minute, and then spit it out. Do not swallow the rinse.

What should I do if I accidentally swallow more than the recommended amount?

If you accidentally swallow more than used for rinsing, get medical help or contact a Poison Control Center right away.

Is this mouthwash safe for children?

Children under 6 years of age should consult a dentist or doctor before use. For children under 12, you should instruct them in good rinsing habits and supervise them as necessary.

Are there any contraindications for using this mouthwash?

There are no specific contraindications listed for ACT Total Care Anticavity Fluoride Mouthwash.

What precautions should I take when using this mouthwash?

Keep the mouthwash out of reach of children and do not use it if the safety seal is broken or missing.

Can I use this mouthwash during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this mouthwash during pregnancy or lactation.

How should I store ACT Total Care Anticavity Fluoride Mouthwash?

Store the mouthwash at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Act Total Care Anticavity Fluoride Icy Clean Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Total Care Anticavity Fluoride Icy Clean Mint.
Details

Drug Information (PDF)

This file contains official product information for Act Total Care Anticavity Fluoride Icy Clean Mint, 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 prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older should use the rinse twice daily, following brushing with toothpaste. To administer, the cap should be removed, and 10 milliliters (mL) should be poured, ensuring not to exceed the 10 mL mark indicated on the inside of the cap. The user should vigorously swish the 10 mL of rinse between the teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, individuals should refrain from eating or drinking for 30 minutes to maximize effectiveness.

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 is capable of using the product without assistance.

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

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

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 instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of monitoring for accidental ingestion remains critical to ensure patient safety.

Side Effects

Patients should be aware that if 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. This warning highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

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 Act Total Care Anticavity Fluoride Icy Clean Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Total Care Anticavity Fluoride Icy Clean Mint.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary for children until they are capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of ACT Total Care Anticavity Fluoride Mouthwash during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data 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 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.

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 the patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical assistance immediately or contact a Poison Control Center for guidance. This precaution is crucial to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature to maintain its integrity and effectiveness. Healthcare professionals are advised to inspect the product prior to use; it must not be used if the safety seal is broken or missing, as this may compromise the product's safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended frequency of twice daily following tooth brushing. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if more than the recommended amount is accidentally swallowed. It is important to instruct children under 12 years in proper rinsing techniques to minimize swallowing and to supervise them until they can use the product independently. Patients should also be cautioned not to swallow the rinse and to refrain from eating or drinking for 30 minutes after use.

Drug Information (PDF)

This file contains official product information for Act Total Care Anticavity Fluoride Icy Clean Mint, 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 Act Total Care Anticavity Fluoride Icy Clean Mint, 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

Last AI update:

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.