Luster Premium White

Description

UC Luster Premium White is presented in a 4-ounce dosage form. This product is designed for professional use, featuring a formulation that emphasizes efficacy and quality. The specific composition and characteristics of the product are tailored to meet the needs of dental professionals and their patients.

Uses and Indications

This drug is indicated for the protection against 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 should 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 essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children in this age group as necessary until they are capable of brushing without supervision.

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. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients to be vigilant regarding the quantity used to prevent potential health risks associated with excessive consumption.

Additionally, this product must be stored out of reach of children under the age of 6 years. It is crucial to ensure that caregivers are aware of this precaution to mitigate the risk of accidental ingestion by young children. Proper education on safe storage practices should be emphasized to promote the well-being of pediatric patients.

Side Effects

Patients should be aware that if they accidentally swallow more than the amount used for brushing, they should seek medical help immediately. This warning is crucial to ensure prompt attention and management of any potential adverse effects resulting from excessive ingestion.

In clinical practice, it is important to monitor for any adverse reactions that may arise from improper use of the product. While specific adverse reactions were not detailed in the available data, the emphasis on seeking medical assistance highlights the potential seriousness of swallowing excessive amounts. Therefore, healthcare providers should educate patients on the correct usage to minimize risks associated with accidental ingestion.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary 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.

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. For children aged 6 years and older, it is recommended to brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by a dentist or doctor.

For children aged 6 to 12 years, caregivers should instruct on proper brushing and rinsing techniques to minimize swallowing and should supervise the brushing process as necessary until the child is capable of performing it independently.

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 Luster Premium White (sodium fluoride gel, dentifrice) 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 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

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, it is imperative that healthcare professionals take immediate action. If a patient accidentally ingests an amount greater than what is typically used for brushing, it is crucial to seek medical assistance promptly.

Potential symptoms of overdosage may vary, and healthcare providers should be vigilant in monitoring the patient for any adverse effects. The specific symptoms associated with overdosage are not detailed in the provided information; however, general signs of overdose may include gastrointestinal distress, neurological symptoms, or other systemic reactions.

Management of overdosage should involve a thorough assessment of the patient's condition, including a review of the amount ingested and the time of ingestion. Healthcare professionals are advised to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as necessary.

In summary, any instance of overdosage warrants immediate medical evaluation and intervention to ensure patient safety and mitigate potential complications.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling information, 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)