Zohar Anti Cavity Mouthwash Bubble Gum Flavour

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The recommended method involves vigorously swishing 10 ml (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy. For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of performing the rinsing procedure independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing 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.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of adhering to the recommended usage guidelines cannot be overstated, as improper use may lead to serious health consequences.

Side Effects

Patients should be aware that if more than the recommended amount used for rinsing 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 usage guidelines to prevent adverse outcomes.

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 Zohar Anti Cavity Mouthwash Bubble Gum Flavour (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the recommended usage is once daily after brushing teeth with toothpaste. Patients should vigorously swish 10 ml (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes following rinsing.

Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended for these children until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is necessary prior to use.

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 they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this demographic, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of Zohar Anti-Cavity Mouthwash Bubble Gum Flavour 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, as the potential effects on fetal outcomes are not established. It is advisable to consider the benefits and risks before use in this population.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Zohar Anti-Cavity Mouthwash Bubble Gum Flavour. Therefore, the effects on breastfed infants and the excretion of the product in breast milk remain undetermined. Lactating mothers should consult their healthcare provider for personalized advice regarding the use of this product while breastfeeding.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 that if more than the recommended amount used for rinsing 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 a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, it is advised to discard the product after opening if it is not used within the specified time frame, although this duration is not detailed in the provided information.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 6 years and older, the recommended usage is once daily after brushing teeth. Patients should vigorously swish 10 ml (2 teaspoonfuls) of the rinse between their teeth for 1 minute before spitting it out. It is important not to swallow the rinse and to avoid eating or drinking for 30 minutes post-rinsing. Clinicians should instruct children under 12 years in proper rinsing techniques to minimize swallowing and supervise them as necessary until they can rinse without assistance. For children under 6 years of age, consultation with a dentist or doctor is advised.

Drug Information (PDF)

This file contains official product information for Zohar Anti Cavity Mouthwash Bubble Gum Flavour, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)