Sodium fluoride

Description

5917 Bubble Fresh Toothpaste with Fluoride is a dental care product formulated to provide effective oral hygiene. It contains fluoride, which is known for its role in the prevention of dental caries. The toothpaste is designed to enhance the overall freshness of the mouth while promoting healthy teeth and gums. The specific formulation and concentration of active ingredients contribute to its efficacy in maintaining oral health.

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 or physician.

For children under 6 years of age, it is recommended to use a pea-sized amount of the product to minimize the risk of swallowing. Caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established.

In the case of children under 2 years, the product should be used only as directed by a dentist or physician.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion of an amount exceeding that used for brushing, it is imperative to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately.

Warnings and Precautions

The product is intended for topical use only and must not be swallowed. In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

To ensure safety, this product should be kept out of reach of children under the age of 6 years. It is crucial for healthcare professionals to educate caregivers about the importance of proper storage to prevent accidental ingestion by young children.

In cases of accidental swallowing, prompt action is necessary. Healthcare providers should advise patients and caregivers to seek emergency medical help or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative that the product is not swallowed. In the event of accidental ingestion of an amount greater than that used for brushing, patients are advised to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Additionally, this product should be kept out of reach of children under 6 years of age to prevent accidental ingestion and potential harm.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Bubble Fresh Toothpaste, with 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. For children in this age group, it is recommended to use a pea-sized amount to minimize the risk of swallowing, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established.

In children under 2 years, the product should only be used as directed by a dentist or physician to ensure safety and efficacy.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Consequently, healthcare professionals should exercise caution when considering this medication for lactating mothers. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered if necessary. Breastfed infants may be affected by maternal medication use; therefore, monitoring for any adverse effects is advisable.

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, it is crucial to seek immediate medical assistance. If an individual accidentally ingests more than the recommended amount used for brushing, they should contact a healthcare professional or reach out to a Poison Control Center at 1-800-222-1222 without delay.

Prompt action is essential to ensure the safety and well-being of the individual affected by the overdosage. Healthcare professionals should be prepared to provide appropriate management based on the specific circumstances of the incident.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if they accidentally swallow more than the amount used for brushing. It is important for patients to understand the potential risks associated with excessive ingestion and to act promptly in such situations.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is essential to store the product within the temperature range of 15º to 35ºC (59º to 95ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)