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Truwell Kids Dentiwash

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.02 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 0.02 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
61284-0011

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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 need to vigorously swish the contents of one 11mL packet 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 use.

For children under 12, it's recommended that they be instructed on proper rinsing techniques to prevent swallowing, and they should be supervised until they can use the rinse safely on their own. 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 help prevent swallowing the rinse. It's important to supervise younger children until they can rinse without help. For children under 6 years old, it's best to 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. 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 if it's right for you, don't hesitate to ask your dentist for guidance.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

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. 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 experience any unusual symptoms or reactions, stop using the product and call your doctor for further guidance. Your health and safety are the top priority, so don’t hesitate to reach out for help if needed.

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. Overdosing can lead to serious health issues, so don’t hesitate to reach out for assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to get help right away. Always prioritize your safety and well-being by being aware of the proper steps to take in case of an emergency.

Pregnancy Use

There is currently no specific information available regarding the use of TRUWELL KIDS DENTIWASH during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or products you are considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, so caution is advised. Since the effects on nursing infants have not been thoroughly studied, be sure to keep an eye out for any unusual reactions in your baby after using the product. Your health and your baby's well-being are the top priorities, so staying informed and cautious is key.

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 about how this medication should be used by 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 may affect you 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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

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 or store the 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 rinsing to ensure the best results.

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 someone accidentally swallows more than intended, seek medical assistance or contact a Poison Control Center immediately.

FAQ

How should I use this dental rinse?

You should 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 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 ensure the product works effectively.

Is this product 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.

What precautions should I take when using this product?

Keep it out of reach of children and use it for dental purposes only.

Is there any information regarding use during pregnancy or nursing?

There is no specific information regarding use during pregnancy. Nursing mothers should consult a healthcare professional before use, as there is potential for excretion in breast milk.

Packaging Info

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

Packaging configurations for Truwell Kids Dentiwash.
Details

Drug Information (PDF)

This file contains official product information for Truwell Kids 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 post-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 may be necessary until the child is capable of using the product independently. For children under 6 years of age, consultation with a dentist or physician is advised 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 oral cavity and related dental procedures. Proper preparation and handling techniques should be followed to maintain the integrity of the product and ensure patient safety.

Dosing should be determined based on the specific clinical scenario and patient needs, adhering to established guidelines for dental applications. It is essential to monitor the patient for any adverse reactions during and after administration.

Healthcare providers are advised to consult relevant clinical protocols and guidelines to optimize dosing regimens and administration techniques tailored to individual patient circumstances.

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

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 and intervention.

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

Packaging & NDC

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

Packaging configurations for Truwell Kids 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

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of TRUWELL KIDS DENTIWASH during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. As with any medication, the potential risks and benefits should be carefully weighed in the context of individual patient circumstances. Women of childbearing potential should be counseled accordingly.

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 a nursing infant are not well studied; it is recommended to monitor for any adverse reactions in the infant.

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 these contexts.

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 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 configurations suitable for dental use only. It is essential to keep the product out of reach of children to ensure safety.

Storage conditions should be carefully observed to maintain product integrity. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed. Special handling needs should be adhered to as per standard protocols for dental products.

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 in 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 Kids 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 Kids 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.