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Act Whitening Anticavity Gentle 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)
Marketed in the U.S.
Since 2019
Label revision date
July 1, 2024
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
Marketed in the U.S.
Since 2019
Label revision date
July 1, 2024
Manufacturer
Chattem, Inc.
Registration number
M021
NDC root
41167-0983

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Drug Overview

ACT WHITENING ANTICAVITY FLUORIDE MOUTHWASH is a mouthwash designed to help prevent dental cavities. It contains fluoride, which is a mineral known for its ability to strengthen tooth enamel and protect against decay. This mouthwash comes in a gentle mint flavor and is available in a 16.9 fl oz (500 mL) bottle, making it easy to incorporate into your daily oral hygiene routine. By using this product regularly, you can support your dental health and maintain a bright smile.

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

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 12 and older, rinse twice a day after brushing your teeth. Measure out 10 milliliters (which is about 2 teaspoonfuls) of the rinse, swish it vigorously between your teeth for 1 minute, and then spit it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're supervising a child under 12, make sure to help them until they can use the rinse on their own. For children in this age group, it's best to consult a dentist or doctor before use to ensure it's appropriate for them.

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. Additionally, if you experience any oral irritation or tooth sensitivity while using the product, stop using it and consult your dentist for further advice.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always prioritize your safety and well-being by following these guidelines.

Side Effects

If you experience oral irritation or tooth sensitivity while using this product, it's important to stop using it and consult your dentist. Additionally, keep this product out of reach of children. If a child accidentally swallows more than the amount intended for rinsing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

If you experience oral irritation or tooth sensitivity while using this product, it’s important to stop using it and consult your dentist for further advice.

Make sure to keep this product out of reach of children. If a child accidentally swallows more than the amount intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so don’t hesitate to get help if needed.

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. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to act quickly. Always prioritize your health and safety by reaching out for help if you’re unsure.

Pregnancy Use

Currently, there is no information available about the use of ACT Whitening Anticavity Gentle Mint 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 is always best 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 recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a dentist or doctor before using this product. For children aged 12 and older, they can use it twice a day after brushing their teeth with toothpaste.

Always supervise younger children while they are using the product until they are able to use it safely on their own. This ensures they are using it correctly and helps prevent any potential issues.

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 there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions do not address how your kidney health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have renal impairment (kidney issues). Your doctor can help determine the best approach based on your individual health needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 health conditions you have to receive the best care possible.

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 medication topically, specifically as a mouth rinse. For adults and children aged 12 and older, rinse with 10 milliliters (2 teaspoonfuls) twice a day after brushing your teeth. Vigorously swish the rinse between your teeth for 1 minute, then spit it out—do not swallow it. After rinsing, avoid eating or drinking for 30 minutes to allow the medication to work effectively. If you're supervising a child, make sure they can use the rinse safely without assistance.

FAQ

What is ACT Whitening Anticavity Fluoride Mouthwash?

ACT Whitening Anticavity Fluoride Mouthwash is a mouthwash product that aids in the prevention of dental cavities and has a gentle mint flavor.

How should I use this mouthwash?

For adults and children 12 years and older, use twice a day after brushing your teeth. Vigorously swish 10 milliliters (2 teaspoonfuls) for 1 minute and then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

What should I do if I accidentally swallow the mouthwash?

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

Can children under 12 years use this mouthwash?

Children under 12 years of age should consult a dentist or doctor before use.

Are there any warnings associated with this mouthwash?

Yes, stop use and consult a dentist if you experience oral irritation or tooth sensitivity. Keep out of reach of children.

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

There is no specific information regarding the use of this mouthwash during pregnancy or lactation.

How should I store this mouthwash?

Store the mouthwash at room temperature and do not use it if the safety seal is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Act Whitening Anticavity Gentle Mint (sodium fluoride 0.02 (0.009 w/v fluoride ion)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Whitening Anticavity Gentle Mint.
Details

Drug Information (PDF)

This file contains official product information for Act Whitening Anticavity Gentle 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 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 12 years of age and older should use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 milliliters (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 following the rinsing procedure to ensure optimal efficacy.

For children under 12 years of age, it is advised to consult a dentist or physician prior to use. Caregivers should supervise children as necessary until they demonstrate the ability to use the rinse without assistance.

Contraindications

There are no specified contraindications for this product.

However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center. Additionally, users should discontinue use and consult a dentist if oral irritation or tooth sensitivity occurs.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Oral Irritation and Tooth Sensitivity In the event of oral irritation or tooth sensitivity, it is imperative to discontinue use immediately and consult a dentist for further evaluation and management.

Pediatric Safety This product should be kept out of reach of children. In cases where more than the recommended amount for rinsing is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients may experience oral irritation or tooth sensitivity while using the product. In such cases, it is advised to stop use and consult a dentist for further evaluation and management.

Additionally, it is important to keep the product out of reach of children. If a child accidentally swallows more than the amount intended for rinsing, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Act Whitening Anticavity Gentle Mint (sodium fluoride 0.02 (0.009 w/v fluoride ion)). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Act Whitening Anticavity Gentle Mint.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a dentist or doctor prior to use. For adolescents and adults aged 12 years and older, the recommended usage is twice a day following brushing with toothpaste. It is important to supervise younger children as needed until they are capable of using the product independently.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of ACT Whitening Anticavity Gentle Mint mouthwash during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential about the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed.

Additionally, patients should be instructed to discontinue use and consult a dentist if they experience any oral irritation or tooth sensitivity. It is important for patients to be aware of these potential issues to ensure their safety and well-being while using the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Additionally, healthcare professionals should ensure that the safety seal is intact before use; the product should not be utilized if the safety seal is broken or missing. Proper handling and storage conditions are crucial for ensuring the product's safety and effectiveness.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children aged 12 years and older. Patients should use the rinse twice daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters (2 teaspoonfuls) of the rinse between the teeth for 1 minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinse. Clinicians should supervise children as necessary until they are capable of using the product without assistance.

Drug Information (PDF)

This file contains official product information for Act Whitening Anticavity Gentle 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 Whitening Anticavity Gentle 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.

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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.