Shopkins Mouth Wash

Description

The product is a mouthwash formulated specifically for children. It contains Sodium Fluoride as the active ingredient at a concentration of 0.05% (0.02% w/v). The mouthwash is presented as a clear, blue liquid with a bubblegum flavor. Inactive ingredients include water, glycerin, sorbitol, sodium benzoate, flavor, citric acid, and Blue 1 (color). The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities. It is designed to help maintain oral health by reducing the risk of dental caries.

Dosage and Administration

Adults and children aged 6 years and older are advised to use the mouthwash daily following their normal brushing routine. Prior to the use of the mouthwash, it is essential to rinse the toothpaste from the mouth thoroughly.

For administration, the recommended dosage is 15 ml (equivalent to 3 teaspoonfuls). The mouthwash should be rinsed or gargled in the mouth for a duration of 30 seconds. After gargling, the solution must be spat out. It is imperative that the mouthwash is not swallowed.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or the individual should contact a poison control center without delay.

Should accidental digestion occur, it is crucial to seek professional assistance or reach out to a poison control center promptly. These measures are essential to ensure the safety and well-being of individuals who may be exposed to the product inadvertently.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a poison control center immediately.

No specific side effects or adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Shopkins Mouth Wash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek professional assistance or contact a poison control center immediately.

For children aged 6 years and older, the recommended usage involves daily application after normal brushing. Patients should rinse their mouths to remove toothpaste prior to use. The mouthwash should be used by rinsing or gargling for 30 seconds with 15 ml (3 teaspoonfuls) and then spitting it out. It is important to instruct pediatric patients not to swallow the mouthwash.

Geriatric Use

There is no specific information regarding the use of Shopkins Mouth Wash in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or complications is advisable in this population.

Pregnancy

There is no specific information regarding the use of Shopkins Mouth Wash (sodium fluoride liquid) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

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.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a poison control center without delay if an accidental ingestion occurs.

Symptoms of overdosage may vary depending on the substance involved; however, specific symptoms are not detailed in the provided information. Therefore, it is crucial for healthcare providers to monitor the patient closely for any signs of adverse reactions or complications that may arise from the overdosage.

Management of an overdosage should be guided by the severity of the symptoms and the specific substance involved. Healthcare professionals are encouraged to follow established protocols for the assessment and treatment of overdosage cases, which may include supportive care and symptomatic treatment as necessary.

In summary, prompt action is essential in cases of overdosage, and healthcare professionals should ensure that patients are aware of the importance of seeking immediate medical help or contacting a poison control center.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of accidental digestion, patients should be instructed to seek professional assistance or contact a poison control center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a configuration that ensures safety and efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. The mouthwash should not be swallowed; if accidental ingestion occurs, it is crucial to seek professional assistance or contact a poison control center immediately.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and extreme temperatures. Proper handling is necessary to maintain the integrity of the product, and users are advised to follow all safety guidelines provided.

Additional Clinical Information

The product is administered via the dental route and is intended for daily use following regular brushing. Patients should rinse their mouths to remove toothpaste prior to application, using 15 ml (3 teaspoonfuls) of the mouthwash for rinsing or gargling for 30 seconds before spitting it out. Swallowing the mouthwash is contraindicated.

Clinicians should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients are instructed to seek professional assistance or contact a poison control center immediately.

Drug Information (PDF)

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

View product document (PDF)