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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
61284-0012

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Drug Overview

This medication is designed for use by adults and children aged 6 years and older to help maintain oral health. It is typically used as a mouth rinse, which you should use twice a day after brushing your teeth. To use it, you will swish the contents of one 11mL packet vigorously between your teeth for one minute before spitting it out. It’s important not to swallow the rinse and to avoid eating or drinking for 30 minutes after using it.

For children under 12, it's recommended to supervise their rinsing habits to ensure they do not swallow the rinse. If you have a child under 6, 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 it 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 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. When using this product, make sure to follow the instructions provided by your dentist or healthcare provider to ensure safe and effective use. Always remember that this medication is not meant for any other purpose outside of dental care. If you have any questions about how to use it or its intended use, don’t hesitate to ask your healthcare professional for guidance.

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

Using this medication may lead to some adverse reactions. If you accidentally swallow more than what is intended for rinsing, it’s important to seek medical help or contact a Poison Control Center immediately.

While specific side effects are not detailed here, it's always a good idea to monitor how you feel after using any medication and report any unusual symptoms to your healthcare provider. Your safety is a priority, so don’t hesitate to reach out if you have concerns.

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 the product and call your doctor for advice. Your health and safety 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. Acting quickly can help prevent any serious health issues.

Signs of an overdose may not always be obvious, so it's crucial to be vigilant. If you notice any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, your safety is the top priority, and getting help promptly can make a significant difference.

Pregnancy Use

When considering the use of TRUWELL DENTIWASH (sodium fluoride liquid) during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no established guidance on how this product may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including dental rinses. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for TRUWELL DENTIWASH does not provide specific information about its use in nursing mothers or any considerations related to lactation. This means there are no established guidelines or data regarding how this product may affect your milk production or your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. They can help you make informed decisions that prioritize your health and the well-being of 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, it's best to 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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 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 determine the best course of action based on your individual situation.

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

It’s important to keep this product out of reach of children to ensure their safety. This product is intended for dental use only, so please use it as directed by your dental professional.

When handling the product, make sure to follow any specific instructions provided by your dentist to ensure safe and effective use. Always prioritize safety and proper usage to achieve the best results.

Additional Information

You should use this dental rinse twice a day after brushing your teeth. For adults and children aged 6 years and older, take one 11mL packet, swish it vigorously between your teeth for 1 minute, and then spit it out. Remember not to swallow the rinse, and avoid eating or drinking for 30 minutes after using it.

If you're supervising a child under 12, make sure to teach them good rinsing habits to prevent swallowing the rinse. If a child accidentally swallows more than intended, consult a dentist or doctor immediately, or contact a Poison Control Center for assistance.

FAQ

How should I use this dental rinse?

Use the rinse 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 used for rinsing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

What should I do after rinsing?

Do not eat or drink for 30 minutes after rinsing to allow the product to work effectively.

Is this rinse safe for children?

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

Are there any contraindications for this rinse?

No contraindications are listed for this rinse.

Is this rinse safe to use during pregnancy or while nursing?

No specific information regarding safety during pregnancy or nursing is provided.

What should I do if I accidentally swallow the rinse?

If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Is this rinse intended for any use other than dental?

No, this rinse is for dental use only.

How should I store this rinse?

Keep out of reach of children.

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

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

Uses and Indications

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

For children under 12 years of age, it is recommended that caregivers 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 physician is required prior to use.

No teratogenic or nonteratogenic effects have been reported 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 dental setting to maintain safety and efficacy. Proper preparation and adherence to the recommended guidelines are essential for optimal patient outcomes.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 of the potential adverse reactions associated with the use of this product. In the event that 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 importance of adhering to the recommended usage guidelines to prevent serious health consequences. Patients are encouraged to remain vigilant and to consult healthcare professionals if any concerns arise regarding the use of this product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 this 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

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for TRUWELL DENTIWASH. Therefore, healthcare professionals should exercise caution when considering the use of this product in lactating mothers. The potential effects on breastfed infants and the excretion of the drug in breast milk remain undetermined.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

This product is supplied in a configuration 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. Specific temperature ranges for storage are not provided; however, it is advisable to keep the product at room temperature.

Special handling requirements include ensuring that the product is not exposed to extreme temperatures or conditions that may compromise its efficacy.

Additional Clinical Information

The product is administered via the dental route, with a recommended frequency of twice daily for adults and children aged 6 years and older. Patients should use one (1) 11mL packet after brushing their teeth, vigorously swishing the contents between their teeth for one minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinse.

Clinicians should instruct parents to supervise children under 12 years of age to ensure proper rinsing habits and minimize the risk of swallowing. If a child accidentally swallows more than the recommended amount, it is advised to consult a dentist or doctor and seek immediate medical assistance or contact a Poison Control Center.

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.