Cloveden Sensitive Care Tooth

Description

The product, identified by SPL Code 34089-3, is a sensitive toothpaste formulated to alleviate dental sensitivity. It contains active ingredients specifically aimed at providing relief from sensitivity, while a selection of inactive ingredients enhances its texture and flavor. This toothpaste is engineered to create a protective barrier over sensitive areas of the teeth, contributing to overall oral comfort.

Uses and Indications

This drug is indicated for the protection of sensitive teeth and the removal of plaque, contributing to its anti-plaque properties. It is also indicated for the prevention of tooth decay through the incorporation of fluoride, which helps to maintain the strength and whiteness of teeth. Additionally, this drug aids in keeping the mouth clean and refreshing the oral cavity, effectively removing bad breath and enhancing aesthetic appeal.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Healthcare professionals are advised to instruct patients to apply an appropriate amount of the product to a toothbrush. This application should occur twice daily, specifically in the morning and evening. Patients should ensure thorough brushing of their teeth following the application to achieve optimal results.

Contraindications

Use is contraindicated in children under the age of 6 if a large amount is swallowed. In such cases, it is imperative to consult a doctor or dentist immediately. No other contraindications have been identified.

Warnings and Precautions

The use of this toothpaste is strictly limited to brushing teeth. It contains fluoride at a concentration of 1,000 ppm, and it is imperative that the total fluoride content does not exceed this level.

For children under the age of six, it is essential to use only a small amount of toothpaste, approximately the size of a pea, and to ensure that its application is supervised by a guardian. This precaution is necessary to prevent the risk of washing away or swallowing the toothpaste. In the event that a child under the age of six ingests a large quantity of the toothpaste, immediate consultation with a healthcare professional, such as a doctor or dentist, is required.

To ensure safety, this product must be stored out of reach of children under six years of age. Additionally, it is critical to retain the toothpaste in its original container. Transferring the product to another container may lead to accidents or compromise the quality of the product due to misuse. Therefore, the original container should be kept tightly closed when not in use.

In case of accidental ingestion of a large amount by a child under six, emergency medical assistance should be sought without delay.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this toothpaste. It is advised that the product be used exclusively for brushing teeth. The fluoride content of this toothpaste is 1,000 ppm, and it is essential that the total fluoride content remains at or below this level.

For children under the age of six, it is recommended to use only a small amount of toothpaste, approximately the size of a pea, and to ensure that it is used under the supervision of a guardian to prevent washing or swallowing. In the event that a child under the age of six swallows a large amount of toothpaste, it is crucial to consult a doctor or dentist immediately.

Storage precautions are also important. The toothpaste should be kept out of reach of children under the age of six. Additionally, it is advised to store the product in its original container and keep it tightly closed to prevent accidents or degradation of product quality. Removing the non-drug from its original container and storing it in another container may lead to misuse or compromise the integrity of the product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Cloveden Sensitive Care Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under the age of six should use a small amount of toothpaste, approximately the size of a pea, and should do so under the supervision of a guardian to minimize the risk of washing or swallowing. In the event that a child under six swallows a large amount of toothpaste, it is imperative to consult a doctor or dentist immediately. Additionally, it is essential to store the product out of reach of children in this age group to ensure safety.

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 efficacy, 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 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

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the individual patient's liver status when prescribing this medication.

Overdosage

In cases of overdosage, immediate medical consultation is crucial, particularly for pediatric patients. If a child under the age of 6 ingests a significant quantity of the medication, it is imperative to seek advice from a healthcare professional, such as a doctor or dentist, without delay.

Healthcare providers should be aware of the potential risks associated with overdosage in this age group and take appropriate action to ensure the safety and well-being of the patient. Monitoring for any adverse effects and implementing necessary interventions based on clinical judgment is essential in managing such situations effectively.

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 text.

Patient Counseling

Healthcare providers should advise patients that if a child under the age of 6 swallows a large amount of the product, it is imperative to consult a doctor or dentist immediately. This guidance is crucial to ensure the child's safety and to address any potential health concerns that may arise from such an incident.

Storage and Handling

The product is supplied in an airtight container to ensure optimal preservation of its integrity. It should be stored at room temperature, within the range of 1 to 30 degrees Celsius. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)