Sprinjene

Description

SprinJene™ Fluoride Toothpaste is formulated as a Fresh Boost Gel, incorporating the unique benefits of Black Seed Oil as its key ingredient. This product is certified vegan by VEGAN.ORG and has a net weight of 4.6 ounces (130 grams).

Uses and Indications

This drug is indicated for the prevention of 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 the event of accidental ingestion of amounts exceeding that which is typically used for brushing. 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 of accidental ingestion of an amount exceeding that typically used for brushing, 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 misuse.

Side Effects

Patients should be aware that if 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 highlights the potential seriousness of ingesting excessive amounts of the product, underscoring the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

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

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.

Supervision is necessary for children until they are capable of using the product without assistance. For children aged 2 years and older, it is recommended to brush 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, instruction in proper brushing and rinsing habits is essential to minimize swallowing. The product should not be used in children under 2 years of age unless specifically directed by a dentist or physician.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for SprinJene Fresh Boost (sodium fluoride gel, dentifrice). As such, healthcare providers should exercise clinical judgment when prescribing this product to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Regular monitoring and assessment of efficacy and safety are recommended to ensure optimal therapeutic results in this population.

Pregnancy

There is no specific information regarding the use of SprinJene Fresh Boost (sodium fluoride gel, 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 and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available regarding excretion in breast milk or effects on nursing infants.

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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients that if more than the recommended amount used for brushing is accidentally swallowed, it is important to seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure patient safety and to address any potential health risks associated with accidental ingestion.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

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 this product is not recommended for children under 2 years unless 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)