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Ortho Super Strawberry Fluoride Mouthwash

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Active ingredient
Sodium Fluoride 0.002 mg/10 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
February 23, 2025
Active ingredient
Sodium Fluoride 0.002 mg/10 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
February 23, 2025
Manufacturer
SuperMouth, LLC.
Registration number
M021
NDC root
83729-109

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Drug Overview

Ortho Super Strawberry Fluoride Mouthwash is a specialized mouthwash designed for individuals with braces or other orthodontic appliances. Its unique formulation helps to reach areas in your mouth that regular brushing and flossing may miss, providing additional protection against cavities and promoting oral health.

This fluoride mouthwash comes in a 16 fl oz (473 mL) bottle and is manufactured by SuperMouth. The pleasant strawberry flavor makes it a more enjoyable part of your oral care routine, especially for those undergoing orthodontic treatment.

Uses

Fluoride mouthwash is a helpful tool for maintaining oral health, especially if you have braces or other orthodontic appliances. It can effectively reach areas in your mouth that regular brushing and flossing might miss, ensuring that your teeth stay strong and protected from cavities.

You can use fluoride mouthwash as part of your daily dental care routine to enhance the benefits of your regular oral hygiene practices. It's designed to support your dental health without any known risks of causing birth defects (teratogenic effects) or other non-birth defect related issues.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. This helps mix the ingredients properly. You should use it every day by dispensing 10 mL (milliliters) of the solution. Once you have the right amount, swish it around in your mouth vigorously for 1 minute, and then spit it out. There's no need to rinse your mouth afterward, so you can go about your day without any extra steps.

What to Avoid

It's important to be aware of certain precautions when using this medication. First and foremost, do not use it if the safety seal is broken, as this could indicate that the product is compromised and may not be safe for you.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always prioritize your safety. If you have any concerns or questions about its use, consult with your healthcare provider for personalized advice.

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 rinsing, seek medical help or contact a Poison Control Center immediately. Additionally, do not use the product if the safety seal is broken, as this may indicate that the product is not safe to use.

Warnings and Precautions

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 intended for rinsing, seek medical help or contact a Poison Control Center immediately.

Before using the product, ensure that the safety seal is intact. If the seal is broken, do not use it. Always prioritize your safety and well-being when using any medication or health product.

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 it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during pregnancy.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old to ensure their safety. If a child accidentally swallows more than what is intended for rinsing, you should seek medical help immediately or contact a Poison Control Center for guidance. Always be vigilant and prioritize your child's safety when using any medication or product.

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.

Remember, even in the absence of specific guidelines, your healthcare team can provide valuable insights and monitor for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your doctor about your health and any concerns you may have.

Renal Impairment

If you have kidney issues, 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 problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure your product remains safe and effective, always check that the safety seal is intact before use. If the seal is broken, do not use the product, as this may compromise its safety and effectiveness.

For optimal storage, keep the product in a cool, dry place away from direct sunlight. Following these guidelines will help maintain the quality and safety of the product for your use.

Additional Information

No further information is available.

FAQ

What is Ortho Super Strawberry Fluoride Mouthwash?

Ortho Super Strawberry Fluoride Mouthwash is a fluoride mouthwash specifically formulated for orthodontics, designed to reach areas that brushing and flossing may miss.

How should I use Ortho Super Strawberry Fluoride Mouthwash?

Shake well before using. Dispense 10 mL, swish vigorously for 1 minute, and then spit out. There is no need to rinse.

What are the indications for using this mouthwash?

This fluoride mouthwash is indicated for use in orthodontics to help clean areas that brushing and flossing do not reach.

Are there any contraindications for this mouthwash?

No specific contraindications are mentioned, but do not use if the safety seal is broken.

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

If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Is this mouthwash safe for children?

Keep out of reach of children under 6 years of age.

Are there any warnings associated with this mouthwash?

Yes, do not use if the safety seal is broken, and keep it out of reach of children under 6 years old.

Is there any information regarding the use of this mouthwash during pregnancy or lactation?

No specific information regarding use during pregnancy or lactation is provided in the insert.

Are there any known drug interactions with this mouthwash?

No specific drug interactions are mentioned in the insert.

What is the volume of Ortho Super Strawberry Fluoride Mouthwash?

The mouthwash comes in a volume of 16 fl oz (473 mL).

Packaging Info

Below are the non-prescription pack sizes of Ortho Super Strawberry Fluoride Mouthwash (anticavity mouthwash). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ortho Super Strawberry Fluoride Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Ortho Super Strawberry Fluoride Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Ortho Super Strawberry Fluoride Mouthwash is a specialized formulation designed for orthodontic care, effectively targeting areas that are often missed by brushing and flossing. This mouthwash is presented in a 16 fl oz (473 mL) bottle and is manufactured by SuperMouth®, located at 9737 Aero Drive, San Diego, CA 92123. For inquiries, the contact number is (844) MOUTHCARE.

Uses and Indications

Fluoride mouthwash is indicated for use in orthodontics to effectively reach areas that brushing and flossing may not adequately clean.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. The recommended dosage is 10 mL, to be dispensed and used daily. Patients should swish the solution vigorously in the mouth for a duration of 1 minute before spitting it out. It is important to note that there is no need to rinse the mouth after spitting out the solution.

Contraindications

Use is contraindicated if the safety seal is broken, as this may compromise the integrity and safety of the product. No other contraindications have been specified.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

The product should not be used if the safety seal is broken, as this may indicate potential contamination or compromise of the product's integrity. Healthcare professionals are advised to ensure that patients are aware of these critical warnings to promote safe usage and prevent adverse events.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Additionally, the product should not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity.

These precautions are essential to ensure the safety and well-being of patients using the product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Ortho Super Strawberry Fluoride Mouthwash (anticavity mouthwash). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ortho Super Strawberry Fluoride Mouthwash.
Details

Pediatric Use

Pediatric patients under 6 years of age should not have access to this product, as it poses a risk if ingested. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this product during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. Further monitoring of breastfed infants may be warranted, although no adverse effects have been documented in the available data.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount for rinsing is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, it is important to inform patients not to use the product if the safety seal is broken, as this may indicate that the product is compromised.

Storage and Handling

The product is supplied in packaging that includes a safety seal. It is imperative that the product not be used if the safety seal is broken, as this may compromise the integrity and safety of the product.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and moisture. Specific temperature ranges for storage have not been provided; therefore, it is advisable to maintain standard room temperature conditions.

Care should be taken to handle the product gently to avoid any damage to the packaging or the product itself.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ortho Super Strawberry Fluoride 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 Ortho Super Strawberry Fluoride 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.

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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.