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Luster Premium White

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 12, 2022
Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 12, 2022
Manufacturer
French Transit, Ltd.
Registration number
part355
NDC root
72805-130

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Drug Overview

LUSTER PREMIUM WHITE® is an anticavity fluoride toothpaste designed to help protect your teeth from cavities while also promoting a brighter smile. It works by providing instant whitening effects and is proven to visibly whiten teeth after just one brushing. This toothpaste is gentle on your enamel and is sulfate-free, making it a safe choice for daily oral care. With a refreshing mint flavor, it aims to enhance your brushing experience while ensuring your teeth stay healthy and bright.

Uses

This medication is designed to help protect you against cavities, which are areas of decay on your teeth that can lead to more serious dental issues if not treated. By using this product, you can take an important step in maintaining your oral health and preventing tooth decay.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those concerned about potential risks.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal and at least twice a day. This applies to both adults and children aged 6 years and older. If you're helping a child between 6 and 12 years old, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. You should supervise them as needed until they can brush their teeth on their own.

For children under 6 years old, it's best not to use this product unless a dentist or doctor specifically advises it. Following these guidelines will help ensure proper dental care for you and your family.

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. This precaution helps protect your loved ones and ensures their safety.

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 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. If you have any concerns or experience unusual symptoms, stop using it and call your doctor for 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 can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

There is currently no specific information available about the use of Luster Premium White Now! sodium fluoride paste during pregnancy. This means that the drug insert does not provide details on whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

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 dental care items like this fluoride paste. They can help you make informed decisions that prioritize your health and the health of your baby.

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 under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal and at least twice a day, or as advised by a dentist or doctor.

For children between 6 and 12 years, make sure to teach them proper brushing and rinsing techniques to help reduce the chance of swallowing the product. You should supervise them as needed until they can brush their teeth independently. For children under 6 years, do not use this product unless specifically directed by a dentist or physician.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 10-27°C (50°F-80°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is LUSTER PREMIUM WHITE®?

LUSTER PREMIUM WHITE® is an anticavity fluoride toothpaste designed to help protect against cavities and promote visibly whiter teeth.

How does LUSTER PREMIUM WHITE® work?

It helps protect against cavities and is proven effective for instant whitening, while being enamel safe and gentle.

What is the recommended usage for adults and children over 6?

Brush your teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.

What should I do if a child under 6 accidentally swallows the toothpaste?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Are there any contraindications for using LUSTER PREMIUM WHITE®?

No contraindications are listed for this product.

Is LUSTER PREMIUM WHITE® safe to use during pregnancy?

There is no specific information regarding the use of LUSTER PREMIUM WHITE® during pregnancy, and no contraindications are mentioned.

Can nursing mothers use LUSTER PREMIUM WHITE®?

There are no specific warnings or recommendations regarding the use of this toothpaste by nursing mothers.

What flavor does LUSTER PREMIUM WHITE® come in?

It comes in a mint flavor.

What is the net weight of LUSTER PREMIUM WHITE®?

The net weight of the product is 4 oz (113 g).

How should LUSTER PREMIUM WHITE® be stored?

Store the toothpaste between 10-27°C (50°F-80°F).

Packaging Info

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

Packaging configurations for Luster Premium White.
Details

Drug Information (PDF)

This file contains official product information for Luster Premium White, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

LUSTER PREMIUM WHITE® is an instant whitening anticavity fluoride toothpaste designed to provide visibly whiter teeth after just one brushing. This formulation is enamel safe, gentle, and sulfate-free, ensuring a mild yet effective cleaning experience. The toothpaste is mint-flavored, enhancing the user experience while promoting oral health. Each tube contains a net weight of 4 oz (113 g).

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 6 years and older are advised to brush their teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or physician.

For children aged 6 to 12 years, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance.

Children under the age of 6 should not use this product unless directed by a dentist or physician.

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

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

Packaging configurations for Luster Premium White.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a dentist or physician. It is important to keep the product out of reach of children in this age group. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately.

For children aged 6 years and older, the recommended practice is to brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor. Children aged 6 to 12 years should be instructed in proper brushing and rinsing techniques to minimize swallowing, and supervision is advised until they are capable of using the product without assistance.

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 Luster Premium White Now! sodium fluoride paste in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy, nor does it provide any data on potential risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of a medical professional is crucial to ensure appropriate care and intervention.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert 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 the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 10-27°C (50°F-80°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The route of administration for the product is dental. There is no additional information available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Luster Premium White, 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 Luster Premium White, 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.