Crest 3d White

Description

Crest® 3D WHITE™ Fluoride Anticavity Toothpaste is formulated to provide enamel-safe whitening while effectively removing up to 80% of surface stains, even in hard-to-reach areas. This toothpaste is designed to promote enamel renewal by rebuilding and fortifying weakened enamel. The product is available in a net weight of 4.1 oz (116 g).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

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 of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

For children under 2 years, consultation with a dentist is recommended 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 more than the recommended amount for brushing, immediate medical assistance should be sought 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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should be aware that if an overdose occurs, emergency medical help is necessary. Prompt action is crucial in such situations to ensure patient safety and appropriate management.

Currently, there are no specific instructions regarding the cessation of use or general precautions provided in the available data. Additionally, no laboratory tests have been specified for monitoring parameters related to the safe use of this product. It is advisable for healthcare providers to remain vigilant and exercise clinical judgment in the management of patients using this product.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of proper usage and the potential risks associated with accidental ingestion in young children.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Crest 3d White (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 the product. In the event that more than the recommended amount for brushing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist. To minimize swallowing, a pea-sized amount should be used for children under 6 years. Parents and caregivers should supervise children's brushing until proper oral hygiene habits are established.

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

Geriatric Use

There is no specific information regarding the use of Crest 3D White Enamel Renewal in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or changes in oral health is advisable in this population, given the lack of targeted clinical findings for those aged 65 and older.

Pregnancy

There is no specific information regarding the use of Crest 3D White Enamel Renewal (sodium fluoride paste, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information regarding the use of Crest 3D White Enamel Renewal 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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 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 that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain product quality, the tube must be kept tightly closed when not in use. In the event of contamination after opening, the product should be discarded to prevent any potential risks.

Additional Clinical Information

The product is administered via the dental route. Patients, including 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 that the product is not swallowed; to minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. Clinicians should supervise children's brushing until proper habits are established, and for children under 2 years, consultation with a dentist is recommended.

Drug Information (PDF)

This file contains official product information for Crest 3d White, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)