Shopkins Brush Buddies

Description

The product is a toothpaste identified by SPL code 34089-3. It contains Sodium Fluoride as the active ingredient, which provides fluoride for dental health. The formulation includes several inactive ingredients: Water, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Titanium Dioxide, and various color additives.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities. It is designed to help maintain oral health by reducing the risk of dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Caregivers should supervise children's brushing until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event of accidental swallowing of an amount greater than that typically used for brushing, it is crucial to seek professional medical assistance or contact a poison control center immediately. This precaution is essential to ensure the safety and well-being of the individual involved.

Should accidental digestion occur, immediate professional assistance or contact with a poison control center is also recommended. Prompt action in these situations is vital to mitigate any potential health risks associated with ingestion.

Side Effects

Patients should be aware of the potential adverse reactions 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 a patient accidentally swallows more than the amount used for brushing, it is imperative to seek professional help or contact a poison control center immediately.

These warnings highlight the importance of proper usage and supervision, particularly in young children, to mitigate the risk of serious adverse events.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Shopkins Brush Buddies (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 adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. It is important to supervise children's brushing until good oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is advised before use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

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

Renal Impairment

There is no specific information available 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 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 exceeding that which is typically used for brushing, it is crucial to seek professional medical assistance or contact a poison control center without delay.

Potential symptoms of overdosage may vary, and prompt evaluation by a healthcare provider is essential to determine the appropriate course of action. Management procedures should be initiated based on the clinical presentation and the specific circumstances surrounding the overdosage incident.

Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the importance of adhering to recommended usage guidelines to prevent such occurrences.

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 reach of children to prevent accidental ingestion. In the event of accidental digestion, patients should be instructed to seek professional assistance or contact a poison control center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

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. Additionally, it is essential to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. Patients should avoid swallowing the product, and for children under 6 years of age, a pea-sized amount should be used to minimize swallowing. Supervision of children's brushing is advised until good habits are established. For children under 2 years, consultation with a dentist is recommended.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, it is crucial to seek professional assistance or contact a poison control center immediately. If more than the recommended amount is swallowed, professional help should also be sought.

Drug Information (PDF)

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

View product document (PDF)