Crest

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the protection against 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 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 children's teeth until proper oral hygiene habits are established.

For children under 2 years of age, 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 swallowing of more than the recommended amount, 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. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. This precaution is essential to ensure the safety and well-being of young children who may be at risk of serious harm from improper use.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

In the event of accidental ingestion, particularly in children under 6 years of age, it is crucial to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of keeping the product out of reach of young children to prevent potential harm.

While specific adverse reactions related to clinical trials or postmarketing experiences were not detailed, the emphasis on safety and the need for immediate action in case of accidental ingestion highlights the seriousness of this concern.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be supervised during brushing to establish good oral hygiene habits. A pea-sized amount of the product is recommended for children in this age group to minimize swallowing. It is advised that children under 2 years of age consult a dentist before use.

For children aged 2 years and older, the product should be used to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important to instruct pediatric patients not to swallow the product. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is necessary.

Additionally, the product should be kept out of reach of children under 6 years of age to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of Crest 3D White Brilliance Luminous Purple in geriatric patients. Consequently, there are no dosage adjustments, safety concerns, or special precautions outlined for elderly patients. Healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may influence safety and efficacy. Regular monitoring and assessment of oral health in elderly patients are recommended to ensure optimal outcomes.

Pregnancy

There is no specific information regarding the use of Crest 3D White Brilliance Luminous Purple during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential risks and benefits of using this product during pregnancy.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Crest 3D White Brilliance Luminous Purple. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this product.

Renal Impairment

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

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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. 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. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the 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 more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within a specified period, which is not detailed in the provided information.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)