Sprinjene

Description

SprinJene™ Fluoride Toothpaste is a white boost paste formulated with a net weight of 5.0 ounces (142 grams). The toothpaste features Black Seed Oil as a key ingredient, providing unique benefits associated with its use. This product is certified vegan by Vegan.org, ensuring adherence to vegan standards.

Uses and Indications

This drug is indicated for the prevention of dental caries.

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, preferably after each meal or at least twice daily, as directed by a dentist or physician.

For children aged 2 to 6 years, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing.

In children under 2 years of age, the product should not be used unless specifically directed by a dentist or physician.

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 an amount greater than that used for brushing, 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 and potential harm.

In the event that more than the recommended amount used for brushing 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 and care.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the product out of 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, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Sprinjene (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, immediate medical assistance or contact with a Poison Control Center is advised.

Children aged 2 years and older are recommended to brush their teeth thoroughly, preferably after each meal or at least twice a day, as directed by a dentist or physician. For children aged 2 to 6 years, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the product.

The use of this product is not recommended for children under 2 years of age unless specifically directed by a dentist or physician. Supervision of children is necessary until they are capable of using the product without assistance.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information 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 on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 any 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 readily available to assist medical personnel in determining the appropriate course of action.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPRINJENE WHITE BOOST - sodium fluoride paste, dentifrice.

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.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

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, away from extreme temperatures, and must be protected from freezing.

To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this duration is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients, particularly adults and children aged 2 years and older, to brush their teeth thoroughly, ideally after each meal or at least twice daily, as recommended by a dentist or physician. For children aged 2 to 6 years, it is important to instruct them in proper brushing and rinsing techniques to minimize swallowing. Additionally, the use of the product in children under 2 years should only occur if directed by a dentist or physician. Parents and caregivers should supervise children as necessary until they are capable of using the product without assistance.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)