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Soom Green Mouthwash

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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
August 17, 2021
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
August 17, 2021
Manufacturer
TECOZYME INC
Registration number
part355
NDC root
79717-0010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 in a product designed to help with teeth whitening and reduce bad breath. This product also aids in the prevention of gingivitis (inflammation of the gums) and periodontitis (a serious gum infection that damages the soft tissue and destroys the bone that supports your teeth).

By using this product, you can support your oral health and maintain a brighter smile while addressing common dental concerns.

Uses

You can use this product to help whiten your teeth and reduce bad breath, making your smile brighter and your breath fresher. Additionally, it plays a role in preventing gum diseases like gingivitis and periodontitis, which can lead to more serious dental issues if not addressed.

Rest assured, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) associated with this product, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 6 years and older, you should use this medication by vigorously swishing 11 mL (milliliters) between your teeth twice a day. Make sure to do this for 30 seconds before spitting it out. It’s important that you do not swallow the solution.

For children under 6 years of age, this medication is not recommended for use. Always follow these instructions carefully to ensure safe and effective use.

What to Avoid

It's important to be aware of certain safety guidelines when considering this medication. You should not use this medication if you are a child under 6 years of age. This restriction is in place to ensure the safety and well-being of younger patients.

Additionally, be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Abuse refers to using the medication in a way not prescribed by a healthcare provider, while dependence (a condition where your body becomes reliant on a substance) can develop with improper use. Always follow your healthcare provider's instructions and avoid using this medication in ways that are not recommended.

Side Effects

It's important to be aware of some warnings associated with this medication. You should not use it if you are under 6 years of age. Additionally, if you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately.

These precautions are in place to ensure your safety and well-being while using the product. Always follow the guidelines provided to avoid any potential risks.

Warnings and Precautions

It's important to be cautious when using this medication. You should not use it if you are caring for a child under 6 years of age. If you accidentally swallow more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always follow the recommended usage instructions to ensure safety. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for guidance. Your health and safety are the top priority.

Overdose

If you accidentally swallow more of the 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 it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of SOOM GREEN MOUTHWASH for nursing mothers or during lactation (the period when you breastfeed). This means that the effects of this mouthwash on breast milk or nursing infants have not been studied or documented.

If you are breastfeeding and considering using this product, it may be wise to consult with your healthcare provider to discuss any potential risks or concerns. Your health and the well-being of your baby are important, so getting personalized advice can help you make the best decision.

Pediatric Use

It is important to note that this medication should not be used in children under 6 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions that apply to elderly patients have not been detailed.

If you or a caregiver are considering this medication, it’s important to consult with a healthcare professional who can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize open communication with your doctor 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, 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 the best performance and safety of your product, store it at room temperature. This helps maintain its effectiveness and integrity. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is the purpose of this mouthwash?

This mouthwash helps with teeth whitening, reduces bad breath, and aids in the prevention of gingivitis and periodontitis.

Who can use this mouthwash?

Adults and children 6 years of age and older can use this mouthwash. Children under 6 years of age should not use it.

How should I use this mouthwash?

You should vigorously swish 11 mL between your teeth twice a day for 30 seconds and then spit it out. Do not swallow.

What should I do if I accidentally swallow more than the recommended amount?

If you accidentally swallow more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately.

Are there any teratogenic effects associated with this mouthwash?

No teratogenic effects have been mentioned for this mouthwash.

Is this mouthwash safe for pregnant or nursing women?

The insert does not provide specific information regarding the use of this mouthwash during pregnancy or lactation.

How should I store this mouthwash?

You should store the mouthwash at room temperature.

Packaging Info

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

Packaging configurations for Soom Green Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Soom Green Mouthwash, 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 data.

Uses and Indications

This drug is indicated for the whitening of teeth and the reduction of bad breath. It also aids in the prevention of gingivitis and periodontitis.

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

Dosage and Administration

Adults and children 6 years of age and older are instructed to vigorously swish 11 mL of the solution between their teeth twice daily for a duration of 30 seconds, after which the solution should be spat out. It is imperative that the solution is not swallowed.

The use of this product is not recommended for children under 6 years of age.

Contraindications

Use is contraindicated in children under 6 years of age.

Warnings and Precautions

The use of this product is contraindicated in children under 6 years of age. Administration in this population may lead to adverse effects and is not recommended.

In the event of accidental ingestion of an amount exceeding that intended for rinsing, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is essential to mitigate potential health risks associated with overdose.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is contraindicated for use in children under 6 years of age. In the event that more than the recommended amount intended for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the outlined warnings. However, healthcare providers should remain vigilant for any unexpected reactions in patients, particularly in those who may be at higher risk.

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 Soom Green Mouthwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Soom Green Mouthwash.
Details

Pediatric Use

Pediatric patients under 6 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and its use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

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

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information regarding the use of SOOM GREEN MOUTHWASH in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 that this medication is not recommended for use in children under 6 years of age. It is important to emphasize the necessity of adhering to this guideline to ensure the safety of younger patients.

Additionally, healthcare providers should instruct patients on the importance of proper usage. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. This information is crucial for ensuring prompt and appropriate care in case of an accidental overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Soom Green Mouthwash, 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 Soom Green Mouthwash, 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.