Plak Smacker

Description

Mint Blast is a pharmaceutical product available in a dosage form of 28 grams. The National Drug Code (NDC) for this product is 71775-080-01.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing cavities, including children and adults. Regular use of this drug may contribute to improved oral health by reducing the incidence of caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is recommended to use a pea-sized amount of toothpaste to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

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 typically used for brushing, it is imperative to seek medical assistance or contact a Poison Control Center without delay. This precaution is critical to ensure the safety and well-being of the individual.

Additionally, it is essential to keep this product out of reach of children under 6 years of age. This measure is necessary to prevent accidental ingestion and potential harm to young children, who may be more susceptible to adverse effects.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Additionally, it is crucial to keep this product out of reach of children, particularly those under 6 years of age, to prevent any unintended exposure or ingestion.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

In children aged 2 to 6 years, a pea-sized amount of product should be used to minimize swallowing, and adult supervision is advised until good brushing habits are established. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

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. It is advisable to monitor these patients closely for any 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations concerning lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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

Patients with hepatic impairment have no specific dosage adjustments, special monitoring requirements, or precautions indicated in the available prescribing information. Therefore, it is recommended that healthcare providers exercise clinical judgment when prescribing this medication to individuals with compromised liver function, as the absence of data does not preclude the need for careful consideration of the patient's overall health status and potential risks.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance or contact a Poison Control Center if an individual accidentally ingests more than the recommended amount used for brushing.

Healthcare professionals should be aware that prompt intervention is crucial in managing potential overdosage scenarios. Symptoms of overdosage may vary depending on the specific substance involved, and it is essential to monitor the patient closely for any adverse effects.

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

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on the appropriate course of action.

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 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 configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light to maintain its integrity. Once opened, the product must be discarded to ensure 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, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)