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Periotherapy Healthy Gums

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
February 10, 2021
Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
February 10, 2021
Manufacturer
Dr. Harold Katz, LLC
Registration number
part355
NDC root
72551-253

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If you are a consumer or patient please visit this version.

Drug Overview

TheraBreath Perio Therapy Healthy Gums Toothpaste is a specialized toothpaste designed to help prevent dental cavities. It works by promoting oral health, making it a supportive choice for maintaining healthy gums and teeth. This toothpaste is formulated to address common dental concerns, ensuring that you can take proactive steps in your oral hygiene routine.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth cavity-free is essential for maintaining a bright smile and overall oral hygiene.

Dosage and Administration

It seems that there are no specific dosage or administration details provided for the medication. This means that you should consult your healthcare provider for personalized instructions on how to take or apply the medication. They will guide you on the correct dosage, how to use it, and how often you should do so to ensure it works effectively for you. Always follow their advice to achieve the best results.

What to Avoid

It's important to ensure that any medication you use is kept safe and secure. Specifically, you should keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion or misuse.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always consult with your healthcare provider if you have any questions or concerns about its use.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it's important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. 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 brushing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and well-being.

Additionally, please keep this product out of reach of children under 6 years old to prevent any accidental ingestion. Always prioritize safety when using any health-related products.

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. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be obvious, 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 considering the use of PerioTherapy Healthy Gums - sodium fluoride paste, it's important to note that there is no specific information available about its safety during pregnancy. This means that the drug insert does not provide guidance on how it may affect you or your baby, nor does it mention any necessary dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any new products, including dental care items like this fluoride paste. They can help you make informed decisions that prioritize your health and the health of your baby.

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 the ingredients could be passed into your breast milk, so caution is advised.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product. Always prioritize your and your baby's health by seeking professional guidance.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than what is typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately. Taking these precautions can help ensure your child's safety while using this 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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 need to be adjusted or monitored based on your liver function.

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 liver health and any other medical considerations.

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 the safe use of this product, it's important to handle it with care. The product comes sealed in protective packaging from the laboratory, so if you notice that the seal is missing, do not use it. In case of any spills on fabrics, make sure to wash the affected area immediately to prevent any potential damage.

Proper storage is also crucial. Keep the product in its original packaging until you are ready to use it, and always handle it in a clean environment to maintain its integrity. Following these guidelines will help ensure your safety and the effectiveness of the product.

Additional Information

No further information is available.

FAQ

What is TheraBreath Perio Therapy Healthy Gums Toothpaste used for?

TheraBreath Perio Therapy Healthy Gums Toothpaste aids in the prevention of dental cavities.

Are there any contraindications for using this toothpaste?

No contraindications are listed for TheraBreath Perio Therapy Healthy Gums Toothpaste.

What should I do if I accidentally swallow more than the amount used for brushing?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Is there any specific information regarding use during pregnancy?

No specific information regarding safety concerns or dosage modifications during pregnancy is provided.

Can nursing mothers use this toothpaste?

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

What precautions should I take regarding children?

Keep TheraBreath Perio Therapy Healthy Gums Toothpaste out of reach of children under 6 years of age.

What should I do if the product seal is missing?

If the seal is missing, do not use the product.

What happens if the toothpaste spills on fabrics?

If spilled on fabrics, wash out immediately.

Packaging Info

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

Packaging configurations for Periotherapy Healthy Gums.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraBreath Perio Therapy Healthy Gums Toothpaste is formulated to support oral health. The product is presented in a tube containing 3.5 ounces of toothpaste. The effective date of this formulation is October 3, 2018. The media type associated with this product is image/jpeg, with the reference image labeled as PER-TB-00175R1_TUBE PASTE PERIOTHERAPY 3.5OZ.2018.12.01.jpg.

Uses and Indications

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

Dosage and Administration

The prescribing information does not provide specific dosage instructions, including the recommended dosage range, route of administration, method of administration, or frequency of dosing. Healthcare professionals are advised to refer to the complete prescribing information for detailed guidance on dosage and administration tailored to individual patient needs.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group.

Warnings and Precautions

In the event that more than the recommended amount used for brushing is accidentally ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This precaution is critical to ensure the safety and well-being of the patient.

Additionally, it is essential to keep this product out of the reach of children under 6 years of age. Proper storage and handling are necessary to prevent accidental ingestion and potential harm. Healthcare professionals should advise caregivers on the importance of monitoring the use of this product in young children to mitigate risks associated with accidental swallowing.

Side Effects

Patients should be aware that if 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. 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Periotherapy Healthy Gums.
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

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

Pregnancy

There is no specific information regarding the use of PerioTherapy Healthy Gums - sodium fluoride paste, dentifrice during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

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 the nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

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

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for overdosage treatment, which may involve symptomatic management and specific antidotes if applicable.

In all cases of suspected overdosage, timely communication with poison control and adherence to local guidelines will facilitate optimal patient outcomes.

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 understanding of potential risks associated with the compound 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 the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

This product is supplied in protective packaging to ensure its integrity during storage and handling. It is essential to inspect the packaging before use; if the seal is missing, the product should not be utilized.

In the event of a spill on fabrics, immediate washing is recommended to prevent staining or damage. Proper handling and adherence to these guidelines are crucial for maintaining the product's quality and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Periotherapy Healthy Gums, 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 Periotherapy Healthy Gums, 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.