Dubai Chocolate Flavor

Description

Supermouth Dubai Chocolate Flavor Toothpaste is a fluoride toothpaste formulated to provide effective dental care. The product is presented in a net weight of 3.4 oz (96 g) and features a unique Dubai chocolate flavor. It is manufactured by SuperMouth®, located at 9737 Aero Drive, San Diego, CA 92123. For customer inquiries, the service can be reached at (844) MOUTHCARE.

Uses and Indications

This drug is indicated for the prevention of cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 that caregivers 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 potential risk of accidental ingestion, it is advised to keep this product out of reach of young children. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

While no specific instructions for discontinuation of use were provided, healthcare providers should remain vigilant and assess the need for further evaluation based on individual patient circumstances.

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 used 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 or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dubai Chocolate Flavor (anticavity 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 of age, the product should be used in a quantity no greater than a tiny grain-of-rice smear. For children aged 3 to 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 the product.

Geriatric Use

There is no specific information regarding the use of Dubai Chocolate Flavor Toothpaste in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may necessitate careful monitoring and evaluation.

Pregnancy

There is no specific information regarding the use of Dubai Chocolate Flavor Toothpaste in pregnant patients. The product insert does not provide any statements indicating whether the toothpaste is contraindicated during pregnancy, nor does it outline any potential risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for use in this population. Healthcare professionals should consider the absence of data when advising pregnant patients on the use of this product.

Lactation

There is no specific information regarding the use of Dubai Chocolate Flavor Toothpaste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

There is no specific information 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 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 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. Monitoring for symptoms may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care as needed. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective treatment.

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 available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of 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 require maintaining the product within the specified temperature range as indicated on the label. Proper container requirements must also be followed to ensure the integrity of the product. Special handling needs, if any, are detailed on the label and should be strictly observed to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)