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Dr Dental Care 80ml

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.016 mg/80 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
September 29, 2014
Active ingredient
Sodium Fluoride 0.016 mg/80 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
September 29, 2014
Manufacturer
Jangin Pharm Co. , Ltd.
Registration number
part355
NDC root
69255-030

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You may be interested to know that this product is a mouthwash designed to help prevent oral diseases. It offers an effective way to maintain oral health and hygiene, making it a useful addition to your daily routine. By using this mouthwash, you can support your efforts in keeping your mouth clean and reducing the risk of dental issues.

Uses

This mouthwash is designed to help prevent oral diseases effectively. By using it regularly, you can maintain better oral health and reduce the risk of issues like cavities and gum disease.

It's important to note that this mouthwash has been evaluated for safety and does not have any teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for most users looking to enhance their oral hygiene routine.

Dosage and Administration

To use this medication effectively, start by measuring out 10-15 milliliters of the solution. Rinse your mouth with this amount for 30 seconds. This step is important as it helps ensure the medication works properly and reaches the areas it needs to treat.

Make sure to follow this rinsing process as directed to get the best results from your treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware of some important safety information regarding this medication. It is crucial to keep it out of reach of children under 6 years old. Additionally, avoid exposing the product to direct sunlight and store it at room temperature. Always remember to close the lid tightly after each use.

If you have any known allergies to the ingredients, consult your doctor before using this medication. In the event that a significant amount is accidentally swallowed, drink a large amount of milk and seek medical assistance immediately.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to ensure their safety. Store it at room temperature and avoid direct sunlight. Always remember to close the lid tightly after each use. If you have any allergies to the ingredients, please consult your doctor before using this product.

In case a significant amount is accidentally swallowed, drink a large amount of milk and seek medical help immediately. If you experience any unusual symptoms or have concerns while using this product, it's best to stop taking it and contact your doctor for guidance.

Overdose

If you accidentally swallow a significant amount of this medication, it's important to act quickly. First, drink a large amount of milk to help dilute the substance in your stomach. After that, seek medical help immediately, as professional assistance is crucial in managing an overdose.

Be aware of possible signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, do not hesitate to get help right away. Your safety is the top priority, so always err on the side of caution.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows a significant amount, you should give them a large amount of milk and seek medical help immediately. Always be cautious and monitor your child's access to medications to prevent any accidents.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at room temperature, away from direct sunlight. This helps maintain its effectiveness and safety. After each use, remember to securely close the lid to protect the contents and prevent contamination.

By following these simple storage and handling tips, you can help ensure that your product remains safe and effective for your needs.

Additional Information

You will use this medication topically, which means it is applied directly to the skin or mucous membranes. For oral use, rinse your mouth with 10-15 ml of the solution for 30 seconds. Make sure to follow these directions carefully for the best results.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this mouthwash?

This mouthwash is used for its outstanding oral disease prevention effect.

How should I use the mouthwash?

Rinse your mouth with 10-15ml of the mouthwash for 30 seconds.

Are there any contraindications for this mouthwash?

There are no contraindications listed for this mouthwash.

What should I do if a significant amount is accidentally swallowed?

If a significant amount is swallowed, drink a large amount of milk and seek medical help.

Is this mouthwash safe for children?

Keep this mouthwash out of reach of children under 6 years old.

Are there any warnings I should be aware of?

Avoid direct sunlight, store at room temperature, and close the lid after use. Consult a doctor if you are allergic to any ingredients.

Is this mouthwash safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this mouthwash during pregnancy.

Can nursing mothers use this mouthwash?

There are no specific warnings or recommendations regarding the use of this mouthwash for nursing mothers.

Are there any known drug interactions with this mouthwash?

No specific drug interactions are mentioned for this mouthwash.

What should I do if I have allergies?

Consult your doctor before use if you are allergic to any of the ingredients.

Packaging Info

Below are the non-prescription pack sizes of Dr Dental Care 80ml (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Dental Care 80ml.
Details

Drug Information (PDF)

This file contains official product information for Dr Dental Care 80ml, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

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

Uses and Indications

This drug is indicated for use as a mouthwash with outstanding oral disease prevention effects.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to rinse their mouth with 10-15 mL of the solution for a duration of 30 seconds. This procedure should be performed as directed to ensure optimal effectiveness.

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 adhere to the following warnings and precautions to ensure the safe use of this product.

Children should be kept away from this product, particularly those under the age of 6 years. It is essential to store the product in a cool, dry place, away from direct sunlight, and at room temperature. After each use, the lid must be securely closed to maintain the integrity of the product.

Healthcare professionals should advise patients to consult a physician prior to use if there is any known allergy to the ingredients contained within the formulation. In the event of accidental ingestion of a significant amount, it is crucial to drink a large quantity of milk and seek immediate medical assistance.

Monitoring for any adverse reactions or allergies is recommended, and patients should be encouraged to report any unusual symptoms to their healthcare provider promptly.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years old to prevent accidental ingestion. Additionally, patients are advised to avoid direct sunlight exposure and to store the product at room temperature. After each use, the lid should be securely closed to maintain product integrity.

Before using this product, individuals should consult a healthcare professional if they have known allergies to any of the ingredients. In the event that a significant amount of the product is accidentally swallowed, it is recommended to drink a large amount of milk and seek medical assistance promptly.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Dental Care 80ml (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Dental Care 80ml.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this medication. In the event of accidental ingestion of a significant amount, it is advised to drink a large amount of milk and seek medical assistance promptly.

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 altered pharmacokinetics and pharmacodynamics. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

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. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 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, if a significant amount of the product is accidentally ingested, it is crucial to take immediate action. The individual should drink a large quantity of milk to help mitigate the effects of the overdose. Following this, it is imperative to seek medical assistance promptly to ensure appropriate evaluation and management.

Healthcare professionals should be aware of the potential symptoms that may arise from an overdosage, although specific symptoms are not detailed in the provided information. Therefore, monitoring the patient for any adverse reactions is essential.

Management of an overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended, and further interventions may be required based on clinical judgment and the severity of the symptoms presented.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 that a significant amount is swallowed, patients should be instructed to drink a large amount of milk and seek medical assistance immediately. It is important for patients to understand the potential risks associated with accidental ingestion and the appropriate steps to take in such situations.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product at room temperature, away from direct sunlight, to maintain its efficacy. After each use, the lid must be securely closed to prevent contamination and preserve the quality of the product.

Additional Clinical Information

The product is administered topically, with specific directions for use: patients should rinse their mouth with 10-15 ml of the solution for 30 seconds. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dr Dental Care 80ml, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Dr Dental Care 80ml, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.