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Truwell Dentiwash

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Liquid
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
October 4, 2023
Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Liquid
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
October 4, 2023
Manufacturer
ECOWORLDPHARM CO. , LTD
Registration number
M021
NDC root
61284-0013

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Drug Overview

This product is a mouth rinse designed for adults and children aged 6 years and older. It is used to help maintain oral hygiene by rinsing with the solution twice a day after brushing your teeth. You should vigorously swish the contents of one 11mL packet between your teeth for one minute before spitting it out, and it's important not to swallow the rinse. After using the mouth rinse, you should avoid eating or drinking for 30 minutes to allow it to work effectively.

For children under 12, it's recommended to supervise their use to ensure they rinse properly and minimize swallowing. If you have a child under 6 years old, it's best to consult a dentist or doctor before use.

Uses

You can use this mouth rinse if you are an adult or a child aged 6 years and older. It's recommended to use it twice a day after brushing your teeth with toothpaste. To use the rinse, take one 11mL packet, swish the contents vigorously between your teeth for one minute, and then spit it out. Remember, do not swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

If you have children under 12, make sure to teach them proper rinsing habits to help prevent swallowing the rinse. It's important to supervise younger children until they can rinse without help. For children under 6 years old, consult a dentist or doctor before use.

Dosage and Administration

This medication is intended for dental use only, meaning it should be used specifically for oral health-related issues. It's important to follow your dentist's instructions carefully when using this product to ensure you get the best results.

Make sure to apply or take the medication exactly as directed by your dental professional. If you have any questions about how to use it or if it’s right for you, don’t hesitate to ask your dentist for clarification. Your oral health is important, and using this medication correctly can help you maintain it effectively.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of 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 for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Always use this product as directed and be mindful of the amount you use. If you have any concerns or experience unusual symptoms, don’t hesitate to stop using it and call your doctor for guidance. Your health and well-being are the top priority.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

When considering the use of TRUWELL DENTIWASH (sodium fluoride liquid) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is advisable to consult with your healthcare provider before using TRUWELL DENTIWASH. They can provide personalized guidance based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of TRUWELL DENTIWASH for nursing mothers. This means that the effects of this product on breast milk or nursing infants have not been studied or documented.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children. For adults and children aged 6 years and older, it can be used twice a day after brushing your teeth. If your child is under 12, make sure to teach them good rinsing habits to help prevent swallowing the product. Always supervise younger children until they can use it safely on their own.

If your child is under 6 years old, please consult a dentist or doctor before use. Additionally, if your child accidentally swallows more than the recommended amount, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure safety and effectiveness, it’s important to keep this product out of reach of children. This product is intended for dental use only, so please do not use it for any other purpose. Always handle it with care to maintain its integrity and effectiveness.

If you have any questions about how to use this product safely, consult your dental professional for guidance.

Additional Information

You should use this dental rinse twice a day after brushing your teeth. To use it, vigorously swish the contents of one 11mL packet between your teeth for one minute, then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

If you have children under 12, make sure to teach them proper rinsing habits to prevent swallowing the rinse. Supervise them as needed until they can rinse without help. If a child accidentally swallows more than intended, seek medical assistance or contact a Poison Control Center immediately.

FAQ

How should I use this dental rinse?

For adults and children 6 years of age and older, use it twice a day after brushing your teeth with toothpaste. Vigorously swish the contents of one (1) 11mL packet between your teeth for 1 minute and then spit it out.

Can I swallow the rinse?

No, do not swallow the rinse. If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

What should I do after using the rinse?

Do not eat or drink for 30 minutes after rinsing to ensure maximum effectiveness.

What precautions should I take for children using this rinse?

Instruct children under 12 years of age in good rinsing habits to minimize swallowing, and supervise them until they can use it without assistance. For children under 6 years of age, consult a dentist or doctor.

Is this rinse safe for pregnant or nursing women?

There is no specific information regarding the use of this rinse during pregnancy or while nursing. Consult your healthcare provider for advice.

Are there any contraindications for this rinse?

No contraindications are listed for this dental rinse.

What should I do if I have more questions about this rinse?

If you have further questions or concerns, consult your healthcare provider for more information.

How should I store this dental rinse?

Keep it out of reach of children and store it as directed on the packaging.

Packaging Info

Below are the non-prescription pack sizes of Truwell Dentiwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Truwell Dentiwash.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

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

Uses and Indications

This drug is indicated for the oral rinse use in adults and children aged 6 years and older. It is to be used twice daily following the brushing of teeth with toothpaste. Patients should vigorously swish the contents of one (1) 11 mL packet between their teeth for one minute before spitting it out. It is essential that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes after rinsing.

For children under 12 years of age, it is recommended to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is advised until the child is capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is required prior to use.

No teratogenic or nonteratogenic effects have been reported.

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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Therefore, no specific conditions or situations warrant avoidance of this product.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that intended for rinsing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

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

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Truwell Dentiwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Truwell Dentiwash.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. For adults and children aged 6 years and older, the recommended usage is twice a day after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing habits to minimize swallowing. Supervision is advised for 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 recommended prior to use. In the event that more than the recommended amount is accidentally swallowed, medical help should be sought immediately, or contact a Poison Control Center.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of TRUWELL DENTIWASH (sodium fluoride liquid) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

No specific information regarding nursing mothers or lactation is provided in the drug insert for TRUWELL DENTIWASH. Therefore, the effects on breastfed infants and the excretion of the drug in human milk are not known. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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, 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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is essential to emphasize the importance of proper storage and handling to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that is suitable for dental use only. It is essential to keep this product out of reach of children to ensure safety.

Storage conditions should be carefully observed to maintain product integrity. The product must be stored in a cool, dry place, away from direct sunlight and moisture. Special handling precautions should be taken to prevent contamination and ensure that the product remains effective for its intended use.

Additional Clinical Information

Patients should use the product via the dental route, rinsing twice daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing the contents of one 11mL packet between the teeth for one minute before spitting it out. It is important not to swallow the rinse and to refrain from eating or drinking for 30 minutes following the rinse.

Clinicians should advise parents to instruct children under 12 years of age on proper rinsing techniques to minimize the risk of swallowing. Supervision may be necessary until children are capable of rinsing without assistance. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Truwell Dentiwash, 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 Truwell Dentiwash, 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.

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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.