Hismile

Description

Wonka Flavor Sodium Fluoride Anticavity Toothpaste is formulated to provide effective cavity protection. The active ingredient, sodium fluoride, contributes to the prevention of dental caries. This toothpaste is designed for topical application in the oral cavity and is intended for use as part of a regular oral hygiene routine. The product is characterized by its unique flavor profile, which enhances the user experience while maintaining its functional efficacy. The effective date for this formulation is July 15, 2024.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

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

Contraindications

The product should not be swallowed, as ingestion may lead to adverse effects. Additionally, it is contraindicated for use in the eye area due to the potential for irritation or injury.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is not intended for ingestion; it must not be swallowed. Additionally, it should not be applied in the eye area to prevent potential irritation or injury.

General Precautions To ensure safety, this product should be kept out of the reach of children under 6 years of age.

Emergency Medical Help Instructions In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought. Contact the Poison Control Center or seek emergency medical help without delay.

Stop Taking and Call Your Doctor Instructions No specific instructions for discontinuation or consultation with a healthcare provider are provided in the current guidelines. However, healthcare professionals should remain vigilant for any adverse reactions and advise patients accordingly.

Side Effects

Patients should be advised of important warnings associated with the use of this product. It is critical that the product is not swallowed and is not used in the eye area. Additionally, the product should be kept out of the reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount is accidentally swallowed, patients or caregivers should seek medical assistance or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of patients, particularly young children who may be at higher risk of adverse effects from improper use.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (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 the product. It is important to instruct children in this age group on proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of using the product without assistance.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use. For those aged 2 years and older, it is recommended that they brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy have been included. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

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 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 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, immediate medical assistance is crucial. If an individual accidentally swallows an amount exceeding that typically used for brushing, it is imperative to seek medical help or contact the Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, although specific symptoms were not detailed in the provided information.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care as needed. It is advisable to follow established protocols for the management of overdosage, which may include decontamination and symptomatic treatment based on the clinical presentation.

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 avoid swallowing the product and to use it only as directed for brushing. Instruct patients that if they accidentally swallow more than the recommended amount, they should seek medical assistance or contact the Poison Control Center immediately. Additionally, it is important to inform patients that the product should not be used in the eye area to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

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, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Clinicians should instruct children under 6 years of age on proper brushing and rinsing techniques to minimize swallowing, and supervision is advised until the child is capable of brushing without assistance. For children under 2 years of age, consultation with a dentist or doctor is necessary before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)