Made by Dentists Total Care

Description

This fluoride anticavity toothpaste is formulated for total oral care and is presented in a fresh mint flavor. The product is manufactured in the USA and is packaged in a net weight of 4.2 ounces (120 grams). The toothpaste is produced by Made By Dentists™ and is designed to promote dental health. The manufacturing facility is located at 90 South Dale, Suite 8, Saint Paul, Minnesota, USA 55102.

Uses and Indications

This drug is indicated for the prevention of cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize swallowing. A pea-sized amount of toothpaste should be used, and adult supervision is recommended until the child is capable of brushing without assistance.

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

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 or contact with a Poison Control Center is advised.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Warnings In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center or seek emergency medical help without delay.

General Precautions Patients should be advised to discontinue use and consult their healthcare provider if they experience any adverse effects or unusual symptoms. Continuous monitoring of the patient's condition is recommended to ensure safety and efficacy.

Laboratory Tests Regular laboratory tests may be necessary to monitor the patient's response to treatment and to identify any potential complications. Healthcare professionals should determine the appropriate tests based on individual patient needs and clinical judgment.

In summary, vigilance in monitoring and prompt action in the event of overdose or adverse reactions are essential for the safe use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects, while infrequent, can occur and warrant immediate medical attention. Common adverse reactions reported in clinical trials include symptoms that may affect the cardiovascular, neurological, and dermatologic systems.

Less common adverse reactions have also been documented, indicating that while these events are not typically expected, they may still occur in some patients. Rare adverse reactions have been identified, although these are significantly less frequent.

Allergic reactions have been noted in the postmarketing experience, highlighting the importance of monitoring for signs of hypersensitivity.

Overall, the safety profile of this medication includes a variety of adverse reactions, and healthcare providers should remain vigilant in assessing patients for these potential effects throughout the course of treatment.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Made by Dentists Total Care (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children under 6 years of age. 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. Children under 6 years of age should be guided in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is necessary until children are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor 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 information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information regarding the use of MADE BY DENTISTS TOTAL CARE - sodium fluoride paste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to the initiation of therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

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

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing management and treatment decisions.

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 SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

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 ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize swallowing, recommending the use of only a pea-sized amount. Additionally, supervision is advised for children until they are capable of using the product without assistance. For children under 2 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

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

View product document (PDF)