Oral-B

Description

Oral-B® is an anticavity fluoride rinse designed to reduce dental cavities by up to 40% compared to brushing alone. This formulation is alcohol-free and features a natural mint flavor, providing a refreshing experience during use. The product is available in a 16.9 oz (500 ml) bottle, making it suitable for regular oral hygiene routines.

Uses and Indications

This drug is indicated for the prevention of dental cavities. Clinical studies have demonstrated that it can reduce the incidence of dental cavities by up to 40% when used in conjunction with regular brushing.

This formulation is alcohol-free, making it suitable for patients who may be sensitive to alcohol-based products.

Dosage and Administration

Adults and children aged 6 years and older should use the rinse once daily, following brushing with toothpaste. The recommended method of administration involves vigorously swishing 10 ml of the rinse, as indicated inside the cap, between the teeth for 1 minute before spitting it out. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness. For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or physician is advised prior to use.

Contraindications

Use is contraindicated if the shrinkband is broken or missing, as this may compromise the integrity of the product. Additionally, the product should not be swallowed.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse. The integrity of the product must be ensured prior to use; therefore, it should not be utilized if the shrinkband is broken or missing.

This product is intended for external use only and should not be swallowed. In the event that an excessive amount is accidentally ingested, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately for guidance.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the product out of the reach of children to prevent accidental ingestion. The product should not be used if the shrinkband is broken or missing, as this may indicate tampering or contamination.

In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is crucial to seek professional assistance or contact a Poison Control Center immediately. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of the reach of children. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

For children aged 6 years and older, the product is to be used once daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Additionally, supervision is advised for children until they are capable of using the product without assistance.

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

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. However, the available data does not provide specific information on dosage modifications, safety considerations, or monitoring protocols for individuals with reduced kidney function. Healthcare professionals should remain vigilant and consult relevant clinical guidelines or additional resources when managing patients with renal impairment to ensure optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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, it is critical to seek professional assistance or contact a Poison Control Center immediately if an amount exceeding that typically used for rinsing is accidentally ingested.

Healthcare professionals should be aware that prompt action is essential in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is advised to ensure appropriate interventions are implemented.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the product out of the reach of children to prevent accidental ingestion. It is important to instruct patients not to use the product if the shrinkband is broken or missing, as this may indicate that the product is compromised.

Patients should be informed that the product is intended for rinsing only and should not be swallowed. In the event that a patient accidentally swallows more than the amount used for rinsing, they should seek professional assistance or contact a Poison Control Center immediately for guidance.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product above freezing to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation or compromise of the product's quality.

Additional Clinical Information

The product is administered via the dental route, recommended for adults and children aged 6 years and older, with a frequency of once daily following tooth brushing. Patients should vigorously swish 10 ml of the rinse between their teeth for one minute before spitting it out, ensuring not to swallow the solution.

Clinicians should counsel patients on the importance of not swallowing the rinse. In the event of accidental ingestion of more than the recommended amount, patients should seek professional assistance or contact a Poison Control Center immediately. It is advised that children under 12 years be instructed in proper rinsing techniques to minimize swallowing, and they should be supervised until they can use the product independently. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Drug Information (PDF)

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

View product document (PDF)