Crest Pro-Health Advanced

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in protecting against cavities by rebuilding weakened enamel and strengthening teeth. Additionally, it provides comprehensive oral hygiene by cleaning the whole mouth and freshening breath.

Limitations of Use: This drug is intended for use as part of a regular oral hygiene routine and should not be considered a substitute for professional dental care.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended dosage is to vigorously swish 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for at least 30 minutes following the use of the rinse to ensure optimal efficacy. 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 rinse independently.

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

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

In cases of accidental ingestion exceeding the recommended dosage, emergency medical help is essential. Prompt action can significantly mitigate potential risks associated with such incidents.

While there are no specific instructions regarding the cessation of use or general precautions provided, healthcare professionals should remain vigilant and monitor patients for any adverse reactions or unusual symptoms that may arise during treatment.

Currently, there are no specified laboratory tests recommended for monitoring the safe use of this product. However, healthcare providers should exercise clinical judgment and consider appropriate assessments based on individual patient circumstances.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years and older are advised to use the product twice daily after brushing their teeth with toothpaste. For children under 12 years of age, it is important to instruct them in proper rinsing habits to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is necessary 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 available regarding the use of Crest Pro-Health Advanced Anti-Cavity Max Cavity Protection Sodium Fluoride Rinse during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

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

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

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 more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and swelling. Additionally, gastrointestinal disturbances have been noted, including nausea and vomiting. Changes in taste perception and oral mucosal irritation have also been reported.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

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

The product is administered orally, with a recommended dosage for adults and children aged 6 years and older being twice daily after brushing teeth. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute before spitting it out, ensuring not to swallow the rinse. It is advised that patients refrain from eating or drinking for 30 minutes following the rinse.

Clinicians should counsel patients, particularly those with children under 12 years, on the importance of good rinsing habits to minimize swallowing. Supervision is recommended for children until they are capable of rinsing without assistance. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

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

View product document (PDF)