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Orapro Fluoride Anticavity

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Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
July 10, 2025
Active ingredient
Sodium Fluoride 1.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
July 10, 2025
Manufacturer
Protegera, Inc.
Registration number
M021
NDC root
83610-1060

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Drug Overview

OraPro Paste is an advanced fluoride anti-cavity toothpaste designed to help protect your teeth against cavities. It works by effectively removing biofilm, which is a sticky layer of bacteria that can lead to dental issues. With its unique formulation, OraPro Paste not only aids in maintaining oral health but also contributes to a brighter, healthier smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects associated with this product. This means it is considered safe in these respects.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between 2 and 6 years old, use only a pea-sized amount of toothpaste and supervise their brushing and rinsing to prevent swallowing. It's essential to watch over them until they can brush their teeth on their own safely.

For children under 2 years old, it's best to consult with a dentist or physician before using any toothpaste. They can provide guidance on the best practices for your little one’s dental care.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize safety by following this guideline. If you have any questions or concerns about using this medication, consult your healthcare provider for personalized advice.

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 address any potential health risks.

Always use this product as directed and keep it out of reach of children to prevent accidental ingestion. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further advice. Your health and safety are the top priority, so don’t hesitate to reach out for help if needed.

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 it comes to using OraPro Fluoride Anticavity Toothpaste during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the drug insert does not provide guidance on how this toothpaste may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

When it comes to using OraPro Fluoride Anticavity Toothpaste while breastfeeding, there is no specific information available about its effects on nursing mothers or lactation (the process of producing milk). This means that there are no known risks or precautions outlined for breastfeeding individuals regarding this toothpaste.

If you have concerns about any products you use while breastfeeding, it's always a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, following the advice of a dentist or physician.

For children between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of swallowing. Continue to supervise them until they can brush their teeth independently. If your child is under 2 years old, consult a dentist or physician before use.

Geriatric Use

While there is no specific information about the use of OraPro Fluoride Anticavity Toothpaste in older adults, it’s important to consider general dental care needs as you age. Older adults may have unique oral health challenges, such as dry mouth or gum sensitivity, which can affect how well a toothpaste works for them.

If you are caring for an older adult, it’s a good idea to monitor their oral health and consult with a dentist about the best dental care products for their specific needs. Always ensure that any dental product used is suitable for their overall health and comfort.

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 medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

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 should be used if you have hepatic impairment (liver issues).

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 determine the best course of action based on your individual situation.

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 about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use the contents within a specified time, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take care when using this product, especially around children. If a child under 6 accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 to 6, use only a pea-sized amount and supervise their brushing and rinsing to reduce the risk of swallowing. It's important to supervise them until they can use the product without assistance. If you have a child under 2 years old, consult a dentist or physician before use. Always keep this product out of reach of young children.

This product is taken orally.

FAQ

What is OraPro Paste?

OraPro Paste is an advanced biofilm removal fluoride anti-cavity toothpaste that helps protect against cavities.

Who can use OraPro Paste?

OraPro Paste is suitable for adults and children 2 years of age and older. Children 2 to 6 years should use a pea-sized amount and be supervised while brushing.

What should I do if a child under 2 years needs to use OraPro Paste?

If a child is under 2 years old, you should ask a dentist or physician before use.

Are there any contraindications for OraPro Paste?

No contraindications are listed for OraPro Paste.

What should I do if more than the recommended amount of OraPro Paste is swallowed?

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

How should I store OraPro Paste?

Store OraPro Paste at room temperature, protect it from freezing, and keep the tube tightly closed when not in use.

Is there any information about using OraPro Paste during pregnancy or while nursing?

No specific information regarding the use of OraPro Paste during pregnancy or lactation is provided.

Are there any known drug interactions with OraPro Paste?

No specific drug interactions are mentioned for OraPro Paste.

Packaging Info

Below are the non-prescription pack sizes of Orapro Fluoride Anticavity (fluoride toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Orapro Fluoride Anticavity.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

OraPro Paste (NDC 83610-1060-1) is a fluoride anticavity toothpaste formulated for advanced biofilm removal. The product is presented in a net weight of 5.2 ounces (147 grams).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of toothpaste. Caregivers should supervise the child's brushing and rinsing habits to minimize the risk of swallowing. Supervision should continue until the child is capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age due to safety concerns. Ensure that the product is kept out of reach of this age group to prevent accidental ingestion or misuse. No other contraindications have been identified.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

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 accidental ingestion and underscores the importance of adhering to the recommended 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 Orapro Fluoride Anticavity (fluoride toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Orapro Fluoride Anticavity.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

In children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing. Caregivers should supervise children until they are capable of brushing without assistance. For infants and children under 2 years of age, consultation with a dentist or physician is advised before use.

Geriatric Use

Elderly patients may use OraPro Fluoride Anticavity Toothpaste; however, the drug insert does not provide specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when recommending this product to geriatric patients, considering the absence of targeted data. Monitoring for any adverse effects or unusual responses in elderly patients is advisable, given the lack of specific guidance in the prescribing information.

Pregnancy

There is no specific information regarding the use of OraPro Fluoride Anticavity Toothpaste during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be evaluated on a case-by-case basis, taking into account the overall oral health needs of the patient.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for OraPro Fluoride Anticavity Toothpaste. Therefore, the effects on lactating mothers and breastfed infants remain undefined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, 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. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 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

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing. To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame, although this timeframe is not detailed in the provided information.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical assistance or contact a Poison Control Center immediately. It is crucial to keep the product out of the reach of children under 6 years of age. For children aged 2 to 6 years, only a pea-sized amount should be used, and caregivers should supervise the child's brushing and rinsing to minimize swallowing. Caregivers should continue to supervise children until they are capable of using the product without assistance. For children under 2 years, consultation with a dentist or physician is recommended.

Drug Information (PDF)

This file contains official product information for Orapro Fluoride Anticavity, 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 Orapro Fluoride Anticavity, 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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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.