ADD CONDITION

items per page

Saltrain Clean Breath

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
Mouthwash
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
November 10, 2020
Active ingredient
Sodium Fluoride 0.02 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
November 10, 2020
Manufacturer
K. Boeun Pharmaceutical Co. , Ltd.
Registration number
part355
NDC root
74724-0020

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 looking for a product designed to help maintain oral hygiene and freshen your breath. This type of product typically involves using a liquid that you swish around in your mouth for about 30 seconds before spitting it out. It's important to follow the instructions carefully, ensuring you do not swallow the liquid.

While specific details about the active ingredients or additional benefits are not provided, using this product as directed can contribute to a cleaner mouth and fresher breath. Always remember to brush your teeth afterward for optimal results.

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended for or how it can help you is not available. If you have questions about this medication or its potential uses, it's best to consult with a healthcare professional who can provide you with the most accurate and relevant information.

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

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Being aware of these warnings can help ensure safety while using the product. Always use it as directed to minimize any risks.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old to prevent accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, so being aware of any unusual symptoms is crucial.

In case of an overdose, don’t wait for symptoms to appear—act quickly. Getting prompt assistance can help ensure your safety and well-being. Always remember that it’s better to be cautious when it comes to your health.

Pregnancy Use

There is currently no information available about the use of SALTRAIN CLEAN BREATH, a sodium fluoride mouthwash, 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 mouthwash or any other medication. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that the ingredients may be passed into your breast milk, so exercising caution is advised when considering its use while nursing. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If your child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately. Taking these precautions can help prevent any potential harm.

Geriatric Use

While there is no specific information about the use of SALTRAIN CLEAN BREATH (sodium fluoride mouthwash) in older adults, it’s important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this mouthwash. They can help ensure that it’s appropriate for your needs and discuss any potential interactions with other medications you may be taking. Always prioritize your health and safety by seeking guidance tailored to your individual situation.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help monitor your liver function and make any necessary adjustments to your 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 interactions between this medication and other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure safety and effectiveness, it’s important to store this product out of reach of children. This helps prevent accidental ingestion or misuse. Remember, this product is intended for dental use only, so please do not use it for any other purpose.

When handling the product, make sure to follow any specific instructions provided by your dental professional to ensure safe and proper use. Always prioritize safety to protect yourself and others.

Additional Information

No further information is available.

FAQ

How should I use this product?

Put an appropriate amount in your mouth, gargle for 30 seconds, spit out, and then brush your teeth.

Is it safe to swallow this product?

No, you should not swallow this product. If more than used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Who should keep this product out of reach?

Keep this product out of reach of children, especially those under 6 years old.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

Is this product intended for any use other than dental care?

No, this product is for dental use only.

Are there any contraindications for this product?

No specific contraindications are listed for this product.

What should I do if I accidentally swallow this product?

If you accidentally swallow more than the amount used for brushing, get medical help or contact a Poison Control Center right away.

Is there any information about drug interactions?

No drug interactions information is provided for this product.

What is the effective date of the information provided?

The effective date for the information is noted as April 2, 2013.

Is there any multimedia content related to this product?

Yes, there is an image labeled 'clean breath.jpg' associated with this product.

Packaging Info

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

Packaging configurations for Saltrain Clean Breath.
Details

Drug Information (PDF)

This file contains official product information for Saltrain Clean Breath, 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 use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known teratogenic or nonteratogenic effects associated 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 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 specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years old to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. This precaution is essential to ensure the safety and well-being of young children who may be at risk of adverse effects from improper use.

Side Effects

Patients should be aware of the following 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. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Saltrain Clean Breath.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. In the event that more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information regarding the use of SALTRAIN CLEAN BREATH (sodium fluoride mouthwash) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects or complications is advisable in this population.

Pregnancy

There is no information available regarding the use of SALTRAIN CLEAN BREATH - sodium fluoride mouthwash during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential about the use of this product during pregnancy.

Lactation

Lactating 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.

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 typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring the patient for any signs of distress is essential.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to have the product's labeling and any relevant medical history available when contacting medical professionals or poison control for guidance.

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 to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Saltrain Clean Breath, 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 Saltrain Clean Breath, 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.