Natoral Korean Ginseng

Description

The product is supplied in a 12 mL sachet, with a total of six sachets per package.

Uses and Indications

This drug is indicated for the control of plaque that leads to gingivitis. It is intended for use in patients seeking to maintain oral health and prevent the onset of gingival inflammation associated with plaque accumulation.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to vigorously swish 20 mL (equivalent to 2/3 FL OZ or 4 teaspoonfuls) between the teeth for a duration of 30 seconds, followed by spitting out the solution. It is imperative that the solution is not swallowed.

For children under 12 years of age, it is advised to consult a dentist or physician prior to use.

In the case of children under 6 years, the product should not be used unless specifically directed by a dentist or physician.

Contraindications

Use is contraindicated in children under 12 years of age. In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Patients should not use this product if they exhibit symptoms such as a painful or swollen gum line, loose teeth, or increased spacing between teeth. These symptoms may indicate periodontitis, a serious form of gum disease, and immediate consultation with a dentist is advised. Additionally, this product is contraindicated for children under 12 years of age.

In the event that gingivitis, bleeding, or redness persists for more than two weeks, it is imperative to discontinue use and seek advice from a dentist.

If an accidental ingestion occurs, particularly if more than the recommended amount for rinsing is swallowed, it is crucial to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication for individuals with a painful or swollen gum line, loose teeth, or increased spacing between the teeth, as these may indicate periodontitis, a serious form of gum disease. Additionally, this product is not recommended for children under 12 years of age.

In the event that symptoms such as gingivitis, bleeding, or redness persist for more than two weeks, patients are advised to stop use and consult a dentist. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Natoral Korean Ginseng (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use the rinse by vigorously swishing 20 mL (2/3 FL OZ or 4 teaspoonfuls) between their teeth for 30 seconds before spitting it out; swallowing the rinse is not advised. For children under 12 years of age, consultation with a dentist or physician is recommended prior to use. Specifically, children under 6 years should not use the rinse unless directed by a healthcare professional.

It is important to note that this rinse is not a substitute for brushing or flossing. Healthcare providers should advise parents to discontinue use and consult a dentist if symptoms such as gingivitis, bleeding, or redness persist for more than 2 weeks. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

There is no specific information regarding the use of Natoral Korean Ginseng menthol mouthwash in geriatric patients. Therefore, healthcare providers should exercise caution when administering this product to elderly patients. It is advisable to monitor for any adverse effects or unusual responses, as the pharmacokinetics and safety profile in this population have not been established. Additionally, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when recommending this mouthwash to geriatric patients.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. Given the lack of established safety data, caution is advised when considering this product in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients that this medication is not recommended for use in children under 12 years of age. It is important to emphasize the necessity of adhering to this guideline to ensure the safety of younger patients.

Additionally, healthcare providers should instruct patients on the importance of proper usage. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. This information is crucial for ensuring prompt and appropriate care in case of an accidental overdose.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should counsel patients that this rinse is not a substitute for brushing or flossing. Patients are advised not to use the rinse if they experience a painful or swollen gum line, loose teeth, or increased spacing between teeth, as these may indicate periodontitis, necessitating immediate dental consultation. If symptoms such as gingivitis, bleeding, or redness persist for more than two weeks, patients should discontinue use and seek advice from a dentist. In the event of accidental ingestion of more than the recommended amount, patients should seek medical assistance or contact a Poison Control Center promptly.

Drug Information (PDF)

This file contains official product information for Natoral Korean Ginseng, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)