Cool Sense Care Plus Mouthwash

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for oral rinsing in adults and children aged 6 years and older. The recommended usage involves rinsing with 10 ml (2 teaspoonfuls) for a duration of 60 seconds, followed by spitting out the solution. It is essential that the rinse is not swallowed. Caregivers should supervise children as necessary until they are capable of using the product without supervision. For children under the age of 6, consultation with a dentist or physician is advised prior to use.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product is indicated for dental use only. Healthcare professionals should ensure that the administration is performed in a controlled environment, adhering to standard dental practices.

Prior to administration, it is essential to prepare the product according to the manufacturer's guidelines. The dosage should be determined based on the specific dental procedure being performed, taking into account the patient's individual needs and clinical judgment.

Administration should be conducted using appropriate techniques to ensure efficacy and minimize discomfort. It is recommended that the healthcare professional monitor the patient throughout the procedure to assess for any adverse reactions or complications.

Dosing intervals and ranges should be tailored to the specific clinical scenario, with careful consideration given to the patient's overall health status and any concurrent medications. Regular reassessment of the patient's response to treatment is advised to optimize outcomes.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

It is imperative to keep this medication out of reach of children under 6 years of age to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to emphasize the importance of not swallowing the medication, as this could lead to serious health risks. Proper patient education regarding the safe handling and administration of this medication is essential to ensure safety and efficacy.

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. The product is not intended for swallowing; if it is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

While specific adverse reactions were not detailed in the provided information, the emphasis on safety precautions highlights the importance of proper usage to mitigate potential risks.

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 Cool Sense Care Plus Mouthwash (sodium flouride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older are instructed to rinse with 10 ml (2 teaspoonfuls) for 60 seconds and then spit out the solution. It is important to supervise children during this process until they are capable of using the product without supervision.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use. The product should be kept out of reach of this age group, and it is critical to emphasize that the rinse should not be swallowed. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Geriatric Use

There is no specific information available 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 COOL SENSE CARE PLUS MOUTHWASH during pregnancy. The drug insert 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 lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when considering the use of this mouthwash in pregnant patients.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to lactating mothers. The effects on a nursing infant are not well studied; it is recommended to monitor for any adverse reactions in breastfed 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 clinical trials for this medication. Consequently, there is no information available 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is accidentally ingested, it is imperative to seek medical assistance or contact the Poison Control Center without delay.

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

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to safeguard the patient's health.

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 compound in these areas.

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 or misuse. It is important to emphasize the necessity of storing the medication in a secure location, away from children's access, to ensure their safety.

Storage and Handling

This product is supplied in packaging that ensures safety and integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion. The recommended storage condition is at room temperature, ensuring that the product maintains its efficacy and safety. No special handling requirements are noted; however, standard precautions should be observed to preserve the quality of the product.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 6 years and older, the recommended usage involves rinsing with 10 ml (2 teaspoonfuls) for 60 seconds, followed by spitting out the solution. It is crucial that children are supervised during this process until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or physician is advised, and the product should be kept out of reach to prevent accidental ingestion.

In the event of accidental swallowing, patients should seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cool Sense Care Plus Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)