Crayola Anticavity Strawberry Flavor

Description

The product features a strawberry flavor, contributing to its sensory profile.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities.

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

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 safety and appropriateness of the product.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used 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. In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, immediate professional assistance should be sought, or the individual should contact a Poison Control Center without delay.

No specific general precautions or laboratory tests have been identified for this product. Additionally, there are no outlined instructions for when to stop taking the product or when to seek emergency medical help. Healthcare professionals are advised to remain vigilant and exercise clinical judgment in the management of any adverse events or concerns that may arise during the use of this product.

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 highlights the potential seriousness of unintentional overexposure in young children.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

Packaging & NDC

Below are the non-prescription pack sizes of Crayola Anticavity Strawberry 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 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 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.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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 warranted based on clinical judgment.

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 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 risks associated with overdosage.

Monitoring for symptoms related to overdosage is also important, although specific symptoms are not detailed in the provided information. Therefore, healthcare professionals should remain vigilant and assess the patient for any unusual signs or reactions following an overdosage incident.

In summary, immediate professional consultation and contact with a Poison Control Center are the recommended actions in the case of overdosage.

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 the 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 preventing adverse effects related to accidental ingestion.

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 excessive heat. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure 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. It is important to instruct patients not to swallow the product.

For children aged 2 to 6 years, a pea-sized amount should be used to minimize swallowing, and adult supervision is recommended during brushing and rinsing to establish good oral hygiene habits. For children under 2 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

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

View product document (PDF)