Clinpro Tooth Creme

Description

Clinpro™ Tooth Crème is a dental paste formulated by 3M ESPE, containing 0.21% w/w sodium fluoride as an active ingredient, which serves as an anti-cavity agent. The product is enhanced with tri-calcium phosphate to support enamel remineralization. It is presented in a 24g tube and has a vanilla mint flavor.

Uses and Indications

Clinpro™ Tooth Crème is indicated for the prevention of dental caries (cavities). This product serves as a topical fluoride treatment designed to strengthen tooth enamel.

There are no specific teratogenic or nonteratogenic effects associated with Clinpro™ Tooth Crème as per the available data.

Dosage and Administration

The active ingredient in this formulation is sodium fluoride, providing 0.950 mg of fluoride ion per gram. This product is intended for oral administration exclusively as a dentifrice.

Healthcare professionals should instruct patients to use the dentifrice as part of their daily oral hygiene routine. It is recommended to apply a small amount of the dentifrice to a toothbrush and brush the teeth thoroughly, ensuring that all surfaces are cleaned. This should be performed at least twice daily or as directed by a dental professional.

Patients should be advised not to swallow the dentifrice and to avoid rinsing with water immediately after brushing to maximize fluoride retention on the teeth. Regular dental check-ups are encouraged to monitor oral health and the effectiveness of fluoride treatment.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no noted risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used in any particular situation.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests have been identified as necessary for monitoring during treatment. Healthcare professionals are advised to remain vigilant and consider the individual patient's health status and any potential interactions with other medications.

In the absence of specific emergency medical help instructions or directives to discontinue use and consult a physician, it is essential for healthcare providers to exercise clinical judgment and provide appropriate patient education regarding the medication's use and any potential side effects that may arise. Regular follow-up and assessment of the patient's response to therapy are recommended to ensure safe and effective treatment.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include rare cases of severe allergic reactions, such as anaphylaxis, angioedema, and urticaria. Other notable allergic reactions may manifest as skin rash.

Common gastrointestinal adverse reactions reported include nausea, vomiting, diarrhea, and abdominal pain. Neurological effects such as headache and dizziness have also been observed among participants in clinical trials.

Cardiovascular reactions may include hypertension, while respiratory symptoms can present as cough and throat irritation. Oral adverse reactions noted include tooth discoloration and increased tartar formation.

Healthcare professionals should be aware of these potential adverse reactions when prescribing this medication and monitor patients accordingly.

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 the current information.

Packaging & NDC

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

Pediatric Use

Pediatric use is not specifically addressed in the available prescribing information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific data.

Geriatric Use

There is no specific information available 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, 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.

Lactation

There are no specific warnings or recommendations regarding the use of Clinpro Tooth Crème in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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

Overdosage of sodium fluoride can lead to significant toxic effects that require prompt medical intervention.

Symptoms of Overdosage Patients experiencing an overdosage may present with a range of symptoms, including nausea, vomiting, diarrhea, abdominal pain, and increased salivation. These initial symptoms can escalate in severity with more pronounced overdosage.

Severe Effects In cases of severe overdosage, individuals may suffer from critical complications such as seizures, respiratory distress, and cardiac arrest. These conditions necessitate immediate and comprehensive medical evaluation and treatment.

Recommended Actions In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare professionals should be prepared to initiate appropriate management procedures based on the severity of the symptoms presented. Prompt intervention is crucial to mitigate the potential life-threatening consequences associated with sodium fluoride 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 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

Patients should be informed that Clinpro™ Tooth Crème is intended for use as an anti-cavity paste. It is essential for patients to use Clinpro™ Tooth Crème as directed by their dentist or healthcare provider to ensure optimal results.

Healthcare providers should advise patients to apply a pea-sized amount of Clinpro™ Tooth Crème to their toothbrush. Patients are encouraged to brush their teeth thoroughly for at least two minutes, twice a day, to effectively benefit from the product.

It is important to instruct patients not to swallow the paste and to spit it out after brushing. Additionally, patients should be made aware that they should avoid rinsing, eating, or drinking for at least 30 minutes after using Clinpro™ Tooth Crème. This practice is crucial for maximizing fluoride retention and enhancing the effectiveness of the treatment.

Patients should also be encouraged to inform their dentist if they experience any adverse reactions or if they have any questions regarding the use of Clinpro™ Tooth Crème. Open communication with their healthcare provider is vital for ensuring safe and effective use of the product.

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 light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)