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The Natural Dentist

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.2430 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
January 25, 2021
Active ingredient
Sodium Fluoride 0.2430 g/100 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 2011
Label revision date
January 25, 2021
Manufacturer
Caldwell Consumer Health LLC
Registration number
part355
NDC root
34362-0270

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 looking for information about a dental product designed for use by adults and children aged 2 years and older. This product is intended to help maintain oral hygiene by promoting thorough brushing of teeth after meals, ideally at least twice a day or as directed by a dentist.

For children under 2 years of age, it is recommended to consult a dentist or physician before use. This guidance ensures that you are using the product safely and effectively for your child's dental care needs.

Uses

It's important to maintain good oral hygiene, and brushing your teeth thoroughly after meals is essential for both adults and children aged 2 years and older. You should brush at least twice a day or follow your dentist's advice. Remember, it's crucial not to swallow the toothpaste.

If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on dental care. This ensures that you are taking the right steps for their oral health.

Dosage and Administration

When it comes to using this medication for children, it's important to follow the right guidelines to ensure safety and effectiveness. For children aged 2 to 6 years, you should use a pea-sized amount of the medication. It's crucial to supervise them while they use it until they develop good brushing habits. This helps ensure they use the right amount and don’t swallow too much.

If your child is under 2 years old, it's best to consult with a dentist before using the medication. They can provide specific advice tailored to your child's needs. Always prioritize your child's safety and oral health by following these recommendations.

What to Avoid

It's important to ensure that you keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to ensure safety and effectiveness.

Side Effects

If you experience tooth sensitivity that persists or worsens while using this product, it's important to stop using it and consult your dentist, as this could indicate a more serious dental issue that requires immediate attention. Additionally, ensure that the safety seal is intact before use.

Please keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

If you experience persistent or worsening sensitivity in your teeth, it's important to stop using the product and consult your dentist. This sensitivity could be a sign of a more serious issue that requires immediate attention.

Make sure to only use the product if the safety seal is intact. Additionally, keep it out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

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 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 regarding its safety or potential risks to you or your developing baby. The drug insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it provide any details about dosage adjustments or special precautions you should take while pregnant.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication to ensure it’s safe for you and your baby.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child is under 2 years of age, you should consult a dentist or physician before use. For children aged 2 to 6 years, you can use a pea-sized amount, but make sure to supervise them until they develop good brushing habits. Always prioritize safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you are caring for an older adult, be vigilant about monitoring for any side effects or changes in health after starting a new medication, and don’t hesitate to reach out to a healthcare professional with any questions or concerns.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 great to know that there are no known interactions between this medication and other drugs or laboratory tests. 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.

Always keep your healthcare provider informed about any changes in your health or medications, as they can help monitor your progress and adjust your treatment if necessary. Open communication is key to your overall health and well-being.

Storage and Handling

To ensure the best performance and safety of your product, store the tube in an upright position with the cap securely closed. This helps maintain the integrity of the contents and prevents contamination. Always handle the tube carefully to avoid spills or damage, and make sure to follow any additional safety guidelines provided with your product. Proper storage and handling are key to ensuring that everything works as intended.

Additional Information

No further information is available.

FAQ

What should I do if I accidentally swallow this product?

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

What are the instructions for children under 2 years of age?

For children under 2 years of age, consult a dentist or physician before use.

How should I supervise children aged 2 to 6 while brushing?

Children aged 2 to 6 should use a pea-sized amount and should be supervised until good brushing habits are established.

What should I do if I experience sensitivity while using this product?

Stop use and ask a dentist if the sensitivity persists or worsens, as it may indicate a serious problem that needs prompt care.

Is this product safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What precautions should I take regarding children and this product?

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

What should I do if the safety seal is broken?

Do not use the product if the safety seal is broken.

How often should I brush my teeth with this product?

Adults and children 2 years and older should brush teeth thoroughly after meals, at least twice a day or as directed by a dentist.

Is there any information about the use of this product during pregnancy?

No specific information regarding pregnancy use is provided, and there are no statements indicating contraindications or risks to the fetus.

Packaging Info

Below are the non-prescription pack sizes of The Natural Dentist (fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for The Natural Dentist.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the oral hygiene of adults and children aged 2 years and older. It is recommended that users brush their teeth thoroughly after meals, at least twice a day, or as directed by a dentist. Users are advised not to swallow the product.

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

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

Dosage and Administration

For children aged 2 to 6 years, a pea-sized amount of the product should be applied. It is essential that caregivers supervise the application and brushing process until the child has developed good oral hygiene habits.

For children under 2 years of age, it is recommended to consult a dentist prior to use to ensure appropriate guidance and safety measures are followed.

Contraindications

Use is contraindicated in children under 6 years of age. Accidental ingestion of amounts greater than those used for brushing may necessitate immediate medical attention or contact with a Poison Control Center.

Warnings and Precautions

Patients should discontinue use and consult a dentist if tooth sensitivity persists or worsens, as this may indicate an underlying dental issue that requires immediate attention.

It is imperative that the product is not used if the safety seal is broken, as this may compromise the integrity and efficacy of the formulation.

To ensure safety, the product must be kept out of reach of children under 6 years of age. In the event that more than the recommended amount is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of certain warnings and adverse reactions associated with the use of this product. If sensitivity persists or worsens, it is advised to stop use and consult a dentist, as sensitive teeth may indicate a serious underlying issue that requires prompt dental care. Additionally, the product should not be used if the safety seal is broken.

It is important to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of The Natural Dentist (fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for The Natural Dentist.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. For children under 2 years, it is advised to consult a dentist or physician before use. In children aged 2 to 6 years, a pea-sized amount should be used, and supervision is recommended until good brushing habits are established.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

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

Lactation

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

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 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 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 may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care as needed. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective treatment.

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. It is important to emphasize the potential risks associated with misuse. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects related to accidental ingestion.

Storage and Handling

The product is supplied in a tube format. It is essential to store the tube in an upright position with the cap securely closed to maintain product integrity. Proper handling and storage conditions are crucial to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for The Natural Dentist, 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 The Natural Dentist, 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.