Super Vanilla

Description

Super Vanilla Fluoride Toothpaste is a fluoride-based formulation designed for oral hygiene. The product is manufactured by SuperMouth, located at 9737 Aero Drive, San Diego, CA 92123. Each tube contains a net weight of 3.4 oz (96 g) and features a super vanilla flavor. The effective date for this product is June 30, 2025. For inquiries, contact can be made at (844) MOUTHCARE.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals seeking to reduce the risk of caries formation.

Dosage and Administration

For children under 3 years of age, a dosage of no more than a tiny grain-of-rice smear is recommended. For children between 3 and 6 years, a pea-sized amount should be used.

The product should be applied to a SuperMouth® toothbrush, and teeth should be brushed thoroughly for at least 2 minutes, twice daily, or as directed by a Dentist or Physician. It is essential for caregivers to supervise the child during brushing and rinsing to minimize the risk of swallowing the product.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals are reminded to emphasize the importance of adhering strictly to the product label instructions. This ensures safe and effective use, minimizing the risk of adverse effects associated with improper usage.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial 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 for brushing is accidentally swallowed, it is imperative 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

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs 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 Super Vanilla (vanilla toothpaste). 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.

For children under 3 years, the product should be used in a quantity no greater than a tiny grain-of-rice smear. For those aged between 3 and 6 years, a pea-sized amount is recommended. It is important to apply the product to a SuperMouth® toothbrush and ensure that teeth are brushed thoroughly for at least 2 minutes, twice a day, or as directed by a Dentist or Physician. Caregivers should supervise the child during brushing and rinsing to minimize the risk of swallowing.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Super Vanilla Fluoride Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise clinical judgment when recommending this product to women of childbearing potential. As with any medication or topical product, it is advisable to consider the overall health and circumstances of the patient when making treatment decisions during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring the patient for any signs of distress is essential.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to have the product's label or information readily available when contacting medical professionals or poison control for guidance on further actions.

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 in the insert.

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 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.

Providers should also remind patients to always follow the instructions on the label to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in accordance with the specifications outlined on the label. It is essential to adhere to the provided instructions for optimal handling and storage.

Storage conditions must be strictly maintained within the recommended temperature range. The product should be stored in a suitable container that protects it from environmental factors. Special handling requirements, if any, should be followed as indicated on the label to ensure the integrity and efficacy of the product.

Healthcare professionals are advised to consult the label for specific details regarding NDC numbers and packaging configurations, as well as any additional storage and handling instructions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)