Hismile

Description

No description information is available for the drug.

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 their teeth without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as it may lead to adverse effects. Additionally, application in the eye area is contraindicated due to the potential for irritation or injury.

Warnings and Precautions

The product is contraindicated for ingestion and should not be applied in the eye area. Healthcare professionals must advise patients to avoid swallowing the product. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

It is essential to educate patients on the importance of adhering to these guidelines to prevent potential adverse effects. No specific laboratory tests are required for monitoring the safe use of this product. However, vigilance in patient education regarding the proper application and potential risks is crucial for ensuring safety.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area. Additionally, the product should be kept out of reach of children under 6 years of age.

In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be at greater risk.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hismile (candy cane flavor sodium fluoride anticavity toothpaste). 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

There is no specific information 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.

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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for HISMILE candy cane flavor sodium fluoride anticavity toothpaste gel. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 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 critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to avoid swallowing the product, as it is intended for external use only. Instruct patients to seek immediate medical assistance or contact a Poison Control Center if they accidentally swallow more than the amount used for brushing. Additionally, it is important to inform patients that the product should not be applied in the eye area to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that the container remains tightly closed when not in use to maintain product integrity.

Care should be taken to protect the product from excessive heat, as this may compromise its quality. Additionally, the product must not be frozen, as freezing can adversely affect its efficacy. Once opened, the product should be discarded if not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients not to swallow the product. It is important to instruct children under 6 years of age on proper brushing and rinsing techniques to minimize the risk of swallowing. Additionally, supervision of children is recommended until they are capable of using the product without assistance.

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)