Anticavity Fluoride

Description

Sodium Fluoride Oral Solution is an anticavity fluoride mouthwash formulated to help prevent dental caries. This solution is presented in a 33.8 fluid ounce (1 liter) container. The product features a minty fresh flavor, enhancing user experience while delivering its therapeutic benefits.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following the brushing of their teeth with toothpaste. For each use, 10 mL (equivalent to 2 teaspoonfuls) of the rinse should be vigorously swished between the teeth for a duration of 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 the rinsing procedure to ensure optimal effectiveness. For children aged 12 years and younger, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required for these children until they demonstrate the ability to use the rinse without assistance.

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

In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, healthcare professionals should remain vigilant and ensure that patients are aware of the potential risks associated with accidental ingestion.

Side Effects

Patients should be aware that if more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the usage guidelines to prevent adverse outcomes.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients should be supervised during use to ensure safety and proper technique. For children aged 6 years and older, the product is indicated for use twice daily after brushing teeth with toothpaste. It is important to instruct children aged 12 years and older in good rinsing habits to minimize swallowing.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use. Care should be taken to keep the product out of reach of children. In the event that more than the recommended amount is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately.

Geriatric Use

Elderly patients may not have specific information regarding the use of Anticavity Fluoride Mouthwash, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when recommending this product to geriatric patients, considering the lack of data on its safety and efficacy in this population. Monitoring for any adverse effects or unusual responses in elderly patients is advisable, given the absence of targeted clinical findings.

Pregnancy

There is no specific information regarding the use of Anticavity Fluoride Mouthwash (Sodium Fluoride) 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 lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when considering the use of this mouthwash in pregnant patients.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 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 related to the specific substance involved is essential, as these may vary based on the nature of the overdosage.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care measures. It is advisable to follow established protocols for the management of overdosage, which may include symptomatic treatment and monitoring of vital signs.

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

Postmarketing experience has indicated that the use of this rinse may lead to temporary staining of the surface of teeth. This effect is considered non-harmful, and it has been noted that adequate brushing can help prevent its occurrence.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use and to act promptly in such situations to ensure their safety.

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 at room temperature to maintain its integrity. Exposure to cold temperatures may cause temporary cloudiness in the product, which is reversible upon returning to room temperature. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily for adults and children aged 6 years and older, following tooth brushing. 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 not to eat or drink for 30 minutes after rinsing. Clinicians should instruct children aged 12 years and younger in proper rinsing techniques to minimize swallowing and supervise them as necessary.

Patient counseling should emphasize keeping the product out of reach of children. In the event of accidental ingestion beyond the recommended amount, immediate medical assistance or contact with a Poison Control Center is advised. Users should ensure the cap is securely closed after use, with a “click” indicating the child-resistant feature is engaged. For children under 6 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

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

View product document (PDF)