Clinpro Tooth Creme

Description

Clinpro™ Tooth Crème, manufactured by 3M ESPE, is an anti-cavity toothpaste formulated with 0.21% sodium fluoride. It is presented in a vanilla mint flavor and is packaged in a tube containing 4 oz (113 g) of product. The National Drug Code (NDC) for this formulation is 48878-3150-4.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of teeth in children until proper oral hygiene habits are established.

For children under 2 years, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential risk of accidental ingestion. In the event of accidental ingestion beyond the recommended amount for brushing, immediate medical assistance 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 and potential harm.

In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that a patient accidentally swallows more than the amount intended for brushing, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more vulnerable to adverse effects from improper use.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 patients under 6 years of age should be kept out of reach of this product. In the event of accidental ingestion of more than the amount used for brushing, 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 after meals or at least twice a day, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Caregivers should supervise children's brushing until proper oral hygiene habits are established. For children under 2 years, consultation with a dentist is recommended prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Clinpro Tooth Crème during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss their individual circumstances with their healthcare provider to determine the appropriateness of using this product during pregnancy.

Lactation

There is no specific information regarding the use of Clinpro Tooth Crème in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the absence of data when advising lactating mothers about the use of this product. The effects on breastfed infants have not been established, and further research may be necessary to determine any potential implications.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on the clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 they accidentally swallow more than the amount used for brushing, 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 improper use of the product.

Storage and Handling

The product is supplied in packaging that includes 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

The medication is administered orally. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, patients should seek medical assistance or contact a Poison Control Center immediately. To reduce the risk of swallowing, it is recommended that a pea-sized amount be used for children under 6 years. Additionally, parents should supervise children's brushing until proper habits are established, and for children under 2 years, consultation with a dentist is advised.

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)