Brush Buddies Crayola Swirl Anticavity Fluoride Watermelon Flavor

Description

Brush Buddies® Crayola Swirl ANTICAVITY FLUORIDE TOOTHPASTE is a dental care product formulated to help prevent cavities. It contains fluoride, which is known for its efficacy in strengthening tooth enamel and reducing the risk of dental caries. The toothpaste is designed for use in a standard oral hygiene routine and is suitable for children. The product features a unique swirl design that combines different colors, enhancing its visual appeal.

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 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 during use.

For children aged 2 to 6 years, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use to ensure appropriate guidance and safety.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion beyond the amount intended for brushing, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately.

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. In the event of accidental swallowing of an amount greater than that used for brushing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately.

No additional general precautions or specific laboratory tests have been identified for this product. Healthcare professionals should remain vigilant and ensure that patients are aware of the importance of adhering to these warnings to promote safe usage.

Side Effects

Patients should be advised to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional help or contact a Poison Control Center immediately. This warning is crucial to ensure the safety of young children who may be at risk of serious adverse reactions from improper use.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Brush Buddies Crayola Swirl Anticavity Fluoride Watermelon Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. For children aged 2 to 6 years, it is recommended to use a pea-sized amount to minimize the risk of swallowing, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist or doctor is advised prior to 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

There is no specific information regarding the use of this drug 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 using this medication.

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.

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 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 assistance without delay.

Healthcare providers should advise the patient or caregiver to contact a Poison Control Center immediately for guidance on the appropriate steps to take. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also recommended, although specific symptoms are not detailed in the provided information. Therefore, vigilance in assessing the patient's condition and readiness to implement management procedures is advised.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information provided regarding animal pharmacology and toxicology. The absence of data in these areas suggests that further investigation may be necessary to fully understand the implications of the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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 they accidentally swallow more than the amount used for brushing, they should seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of 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 room temperature, ensuring that it is protected from excessive heat. Freezing the product is strictly prohibited, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional help or contact a Poison Control Center immediately. To reduce the risk of swallowing, it is recommended to use a pea-sized amount and supervise children's brushing and rinsing until proper habits are established. Additionally, consultation with a dentist or doctor is advised for children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola Swirl Anticavity Fluoride Watermelon Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)