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Ortho Guard

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Active ingredient
Sodium Fluoride 4.4 mg/10 mL
Other brand names
Dosage form
Gel, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1989
Label revision date
December 17, 2023
Active ingredient
Sodium Fluoride 4.4 mg/10 mL
Other brand names
Dosage form
Gel, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1989
Label revision date
December 17, 2023
Manufacturer
Massco Dental A Division of Dunagin Pharmaceuticals
Registration number
M021
NDC roots
63783-400, 63783-401, 63783-403

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

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE is a topical solution that contains 0.044% sodium fluoride, which is designed to help prevent dental decay. This rinse works by providing fluoride, a mineral that strengthens tooth enamel and makes it more resistant to cavities.

You can use ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE as part of your oral hygiene routine to support your dental health. It is particularly beneficial for those looking to reduce their risk of cavities and maintain a healthy smile.

Uses

You can use this product to help prevent dental decay, which is the process that leads to cavities in your teeth. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing issues related to tooth decay. Regular use can be an important step in maintaining a healthy smile.

Dosage and Administration

To use this mouth rinse effectively, make sure to follow the directions provided. If you are an adult or a child aged 6 years and older, you should use the rinse once a day after brushing your teeth with toothpaste. Measure out 10 milliliters (which is about 2 teaspoons) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. After rinsing, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively.

If you have children under 12, be sure to teach them proper rinsing techniques to prevent swallowing the rinse. For children under 6 years old, it's best to consult a dentist or physician before using the product to ensure it's safe for them.

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

When using this product, it's important not to swallow it unless directed by your dentist or physician. If you accidentally swallow more of the solution than intended for rinsing, seek medical help or contact a Poison Control Center right away.

Please be aware that while this product is generally safe when used as directed, following these guidelines is crucial to avoid any potential health risks.

Warnings and Precautions

When using this product, it's important not to swallow it unless directed by your dentist or physician. If you accidentally swallow more of the solution than intended for rinsing, seek medical help or contact a Poison Control Center right away.

Make sure to store the product at room temperature to maintain its effectiveness. Always prioritize your safety and well-being while using this product.

Overdose

If you accidentally swallow more of the solution than intended for rinsing, it’s important to seek medical help right away 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. While there are no specific contraindications listed, caution is advised due to the unclear safety profile for pregnant women. There is also no detailed information available regarding potential risks to the fetus.

Before using this product, you should consult your healthcare provider to discuss any concerns and ensure it is safe for you and your baby. There are no specific dosage modifications recommended for pregnant women, but your healthcare provider can give you personalized advice based on your situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements indicating that the product is excreted in breast milk or that it poses any risk to your infant. This means you can use the product without concern for its effects on your milk production or your baby's health.

Pediatric Use

If you have a child aged 6 years or older, they can use this mouth rinse once a day after brushing their teeth. You should help them measure out 10 milliliters (which is about 2 teaspoons) and have them swish it vigorously between their teeth for 1 minute before spitting it out. It's important that they do not eat or drink anything for 30 minutes after rinsing. For children under 12, make sure to guide them on proper rinsing techniques to prevent swallowing the rinse.

For children younger than 6 years, it's best to consult with a dentist or physician before using this mouth rinse.

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 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 (issues with liver function).

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 great to know that there are no known drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your specific situation. Your safety and well-being are the top priority!

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

You should use this product once a day after brushing your teeth. To do this, vigorously swish 10 milliliters (which is about 2 teaspoons) of the rinse between your teeth for 1 minute, then spit it out. It's important not to eat or drink anything for 30 minutes after rinsing to allow the product to work effectively.

If you have children under 12, make sure to teach them proper rinsing habits to prevent swallowing the rinse. For children under 6, it's best to consult a dentist or physician before use.

FAQ

What is ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE?

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE is a topical solution containing 0.044% sodium fluoride, designed to aid in the prevention of dental decay.

How should I use ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE?

Use once a day after brushing your teeth. Vigorously swish 10 milliliters (2 teaspoons) of the rinse between your teeth for 1 minute, then spit it out. Do not eat or drink for 30 minutes after rinsing.

Is ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE safe for children?

Children under 6 should consult a dentist or physician before use. For children 6 years and older, instruct them in good rinsing habits to avoid swallowing.

What should I do if I accidentally swallow more solution than intended?

If more solution is accidentally swallowed than used for rinsing, get medical help or contact a Poison Control Center immediately.

Is it safe to use ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE during pregnancy?

Safety during pregnancy has not been established. Consult a healthcare provider if you are pregnant or planning to become pregnant before using this product.

Are there any contraindications for using ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE?

No specific contraindications are listed, but caution is advised, especially during pregnancy.

Where can I find more information about ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE?

You can visit the manufacturer's website at www.masscodental.net for more information.

How should I store ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE?

Store the rinse at room temperature.

Packaging Info

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

Packaging configurations for Ortho Guard.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE is a topical solution containing 0.044% sodium fluoride in an acidulated phosphate formulation. This product is manufactured by Massco Dental, a division of Dunagin Pharmaceuticals, located in Gravette, Arkansas. For further information, visit www.masscodental.net.

Uses and Indications

This drug is indicated for the prevention of dental decay. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

The product is to be used as directed. For adults and children aged 6 years and older, the recommended dosage is to use the rinse once daily, following brushing with toothpaste. Patients should vigorously swish 10 milliliters (equivalent to 2 teaspoons) of the rinse between their teeth for a duration of 1 minute before spitting it out. It is important that patients refrain from eating or drinking for 30 minutes after rinsing to maximize effectiveness.

For children under 12 years of age, caregivers should instruct them in proper rinsing techniques to prevent swallowing of the rinse. For children under 6 years, it is advised to consult a dentist or physician prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

When using this product, it is imperative that it is not swallowed unless directed to do so by a dentist or physician. In the event that more solution is accidentally ingested than intended for rinsing, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

To ensure the product's efficacy and safety, it should be stored at room temperature. This precaution helps maintain the integrity of the solution and its intended use.

Healthcare professionals are advised to remain vigilant regarding the potential for accidental ingestion and to educate patients on the importance of adhering to the recommended usage guidelines.

Side Effects

Patients should be advised that this product is not intended to be swallowed unless directed by a dentist or physician. In the event that more solution is accidentally swallowed than what is recommended for rinsing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These warnings highlight the importance of adhering to the prescribed usage to prevent potential adverse reactions associated with improper use.

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.

Packaging & NDC

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

Packaging configurations for Ortho Guard.
Details

Pediatric Use

Pediatric patients aged 6 years and older may use the rinse once daily after brushing their teeth with toothpaste. They should vigorously swish 10 milliliters (10 ml on cap or 2 teaspoons) of the rinse between their teeth for 1 minute and then spit it out. It is important that these patients do not eat or drink for 30 minutes following rinsing.

For children under 12 years of age, caregivers should instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. For children under 6 years, consultation with a dentist or physician is recommended prior to use.

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

Safety during pregnancy has not been established for this product. While specific contraindications are not mentioned, caution is advised due to the unclear safety profile in pregnant women. There is no specific information available regarding risks to the fetus. Additionally, no dosage modifications for pregnant women are provided. It is recommended that healthcare providers be consulted if a patient is pregnant or planning to become pregnant before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an excessive amount of the solution is ingested beyond the intended use for rinsing.

Healthcare professionals should be aware that prompt intervention is essential in managing potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for the assessment and treatment of overdosage cases, ensuring that the patient receives appropriate care based on their clinical presentation.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

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

Patients should use the rinse once a day after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 milliliters (equivalent to 2 teaspoons) of the rinse between the teeth for 1 minute before spitting it out. It is important for patients not to eat or drink for 30 minutes following the rinsing.

Clinicians should advise that children under 12 years of age be instructed in proper rinsing techniques to prevent swallowing the rinse. Additionally, consultation with a dentist or physician is recommended for children under 6 years of age.

Drug Information (PDF)

This file contains official product information for Ortho Guard, 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 Guard, 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.