Haring B Detox Mouthwash

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known 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 restricted to the oral cavity and related dental procedures. Proper techniques for preparation and application should be followed to ensure safety and efficacy. It is essential to adhere to the recommended guidelines for dosage and administration specific to the dental context.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Caution is advised when using this toothpaste due to its fluoride content of 90.5 ppm. Users should take care to avoid swallowing the product and are encouraged to rinse their mouths thoroughly after use. In the event of gum or mouth damage resulting from the use of this toothpaste, it is imperative to discontinue use and seek consultation from a healthcare professional, such as a doctor or dentist.

For children under the age of six, it is recommended to use only a small amount of toothpaste, approximately the size of a pea, and to ensure that usage is supervised by a guardian to prevent sucking or swallowing. If a child under six years old ingests a large quantity of the toothpaste, immediate consultation with a physician or dentist is necessary. Additionally, this product should be kept out of reach of children under six years old to prevent accidental ingestion.

This toothpaste contains sodium benzoate, which may cause slight irritation to the skin, eyes, and mucous membranes. Furthermore, due to the presence of fluoride and ethanol, parental or adult guidance is essential when this product is used by children. Caution should also be exercised when conducting ethanol (alcohol) testing immediately after use, as this product may influence the results of alcohol measurement.

In summary, it is crucial to adhere to these warnings and precautions to ensure safe usage of the toothpaste.

Side Effects

Patients should be aware that this medicine contains sodium benzoate, which may cause slight irritation to the skin, eyes, and mucous membranes. While this reaction is generally considered mild, it is important for patients to monitor for any signs of irritation and to consult a healthcare professional if such symptoms occur.

Drug Interactions

The presence of ethanol in this product may interfere with the accuracy of ethanol testing. Caution is advised when conducting alcohol measurements immediately following the use of this product, as it may yield misleading results. It is recommended to allow sufficient time after use before performing any ethanol testing to ensure accurate readings.

Packaging & NDC

Below are the non-prescription pack sizes of Haring B Detox Mouthwash (allantoin, sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be supervised when using this product, particularly those under the age of six years. It is recommended that a small amount of toothpaste, approximately the size of a pea, be used at a time to minimize the risk of swallowing. In the event that a child under six years old swallows a large amount, immediate consultation with a physician or dentist is advised.

Due to the presence of fluoride and ethanol in this product, guidance from parents or guardians is essential to ensure safe usage. Additionally, it is crucial to keep this product out of reach of children under six years old to prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

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 nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

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

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful assessment and monitoring based on individual patient circumstances.

Overdosage

In cases of overdosage, immediate medical consultation is essential, particularly for vulnerable populations such as children. If a child under the age of 6 years ingests a significant quantity of the medication, it is imperative to seek advice from a physician or dentist without delay.

Healthcare professionals should be aware of the potential risks associated with overdosage and the importance of prompt intervention. Symptoms of overdosage may vary depending on the specific medication involved, and it is crucial to monitor the patient closely for any adverse effects.

Management of overdosage typically involves supportive care and symptomatic treatment. In all instances of suspected overdosage, healthcare providers are encouraged to refer to established clinical guidelines and protocols to ensure appropriate management and patient safety.

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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in configurations suitable for dental use only. It is essential to store the product at room temperature to maintain its efficacy. Additionally, it should be kept out of reach of children to ensure safety during handling and storage.

Additional Clinical Information

Patients should be advised that the product is intended for dental use only. The recommended administration involves holding 10 to 15 ml in the mouth for approximately 30 seconds before spitting it out and brushing teeth. It is crucial for patients to avoid swallowing the product and to rinse their mouths thoroughly after use.

Clinicians should counsel patients on the potential for gum or mouth damage; if such damage occurs, the patient should discontinue use and seek medical advice. For children under six years, a small amount of toothpaste, approximately the size of a pea, should be used under adult supervision to prevent swallowing. In the event of a large ingestion by a child, immediate consultation with a physician or dentist is necessary. Additionally, the product contains sodium benzoate, which may cause slight irritation, and it includes fluoride and ethanol, necessitating adult guidance during use by children. Care should also be taken when testing for ethanol immediately after use, as the product may influence measurement results. Finally, it is important to keep the product out of reach of children under six years old.

Drug Information (PDF)

This file contains official product information for Haring B Detox Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)