Kids Kare

Description

kids kare™ is a toothpaste formulated with 0.24% Sodium Fluoride. It is designed for pediatric use and is available in a berry flavor. The product is packaged in a net weight of 4 oz. (113.4 g).

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 are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

It is important to instruct children under 6 years of age to use only a pea-sized amount of the product to minimize swallowing. Additionally, caregivers should supervise children during brushing to ensure proper technique and safety until the child is capable of brushing without assistance.

The product should not be swallowed. Proper brushing and rinsing habits should be emphasized to children to promote oral health.

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, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of monitoring for accidental ingestion remains critical in ensuring patient safety.

Side Effects

There are currently no specific adverse reactions, warnings, or boxed warnings associated with the use of this product. Clinical trials and postmarketing experiences have not identified any notable side effects. As such, healthcare professionals should continue to monitor patients for any unexpected reactions during treatment.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no known interactions with laboratory tests. 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 Kids Kare (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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For 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. For children under 2 years of age, consultation with a dentist or doctor is necessary prior to use.

To minimize the risk of swallowing, a pea-sized amount of the product should be used for children under 6 years. It is important to instruct these children in proper brushing and rinsing habits and to supervise them as needed until they are capable of brushing without assistance.

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 available 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 informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Kids Kare - Sodium Fluoride Paste, Dentifrice. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants have not been established, and further evaluation may be necessary to ensure safety during breastfeeding.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. It is important to monitor renal function tests in these patients regularly. For individuals with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate the risk of adverse effects associated with decreased kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution should be exercised when administering the drug to patients with liver dysfunction, and careful consideration of the patient's overall health status and liver function is essential in determining the appropriate therapeutic approach.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and treatment protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 for the product associated with SPL code 90375-7.

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 more than the recommended amount used for brushing is accidentally swallowed, they should seek medical 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 a configuration that includes a foil seal under the cap. It is imperative that the product is not used if this seal is torn, cut, or missing, as this may compromise the integrity of the product.

For optimal storage, the product should be kept in a controlled environment. Specific temperature ranges and container requirements are not provided; however, it is essential to ensure that the product is stored in a manner that protects it from contamination and maintains its efficacy. Special handling needs should be observed to prevent any damage to the packaging or the product itself.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)