Luster Premium White

Description

UC Luster Premium White is a dental whitening product available in a 4-ounce dosage form. The formulation is designed to enhance the brightness of teeth, utilizing a proprietary blend of ingredients. The product is presented in a premium white pearl appearance, indicating its high-quality formulation.

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are advised to brush their teeth thoroughly, preferably after each meal, and 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. 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 greater than that used for brushing, immediate medical assistance should be sought. This precaution is critical to ensure the safety and well-being of the individual.

It is imperative to keep this product out of the reach of children under 6 years of age. Proper storage and handling are essential to prevent accidental ingestion and potential harm. Healthcare professionals should advise caregivers on the importance of monitoring the use of this product in young children to mitigate risks associated with misuse.

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 highlights the importance of adhering to the recommended usage to avoid potential adverse effects associated with excessive ingestion.

While specific adverse reactions were not detailed in the provided data, it is crucial for patients to remain vigilant and report any unexpected symptoms or reactions to their healthcare provider. Regular monitoring and communication with healthcare professionals can help ensure safe and effective use of the product.

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 young children. 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. Children between the ages of 6 to 12 years should be instructed in proper brushing and rinsing techniques to minimize swallowing, and they should be supervised as necessary until they are capable of using the product without supervision.

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 no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

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. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this population to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 risks.

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 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 ensure that patients understand the necessity of proper storage to prevent such incidents.

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, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct patients, particularly children aged 6 to 12 years, on proper brushing and rinsing techniques to minimize the risk of swallowing. It is essential for caregivers to supervise children during use until they are capable of using the product independently. The product is not recommended for use in children under 6 years unless specifically directed by a dentist or physician.

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)