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The Humble Co Natural Charcoal

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 1.25 mg/1 mL
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
May 29, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 1.25 mg/1 mL
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
May 29, 2018
Manufacturer
The Humble Company USA, Inc
Registration number
part355
NDC root
72299-000
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, contributing to better oral health. While specific details about how it functions are not provided, its primary purpose is to support you in maintaining a cavity-free smile.

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. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, you should apply toothpaste onto your toothbrush and brush your teeth thoroughly. It's best to do this after each meal or at least twice a day. If you have children under 6 years old, make sure to teach them good brushing and rinsing habits to help prevent swallowing the toothpaste. You should supervise them until they can brush their teeth on their own safely.

If your child is under 2 years old, it's important to consult a dentist or doctor for guidance on how to care for their teeth properly.

What to Avoid

It's important to use this product safely. If you experience any irritation while using it, please stop using it immediately. Additionally, keep this product 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 right away.

By following these guidelines, you can help ensure a safe experience with the product.

Side Effects

If you experience any irritation while using this product, it's important to stop using it immediately. Additionally, keep this product out of reach of children, especially those 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 right away.

Currently, there are no specific adverse reactions or side effects reported for this product.

Warnings and Precautions

If you experience any irritation while using this product, it's important to stop using it immediately. Make sure to keep this product out of reach of children under 6 years old to prevent any accidental ingestion.

In the event that more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center right away. Your safety is a priority, so please take these precautions seriously.

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 this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor about any concerns you may have.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no detailed guidelines or warnings, it’s always a good idea to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you understand any potential risks and ensure the safety of both you and your baby.

Pediatric Use

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 used for brushing, seek medical help or contact a Poison Control Center immediately.

For children aged 2 years and older, you should guide them in proper brushing and rinsing techniques to help reduce the chance of swallowing the product. Always supervise younger children until they can brush their teeth independently. If your child is under 2 years old, please consult a dentist or doctor before use.

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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver 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 apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures below 25°C (77°F). Keeping it within this temperature range helps maintain its effectiveness and safety.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. If you are giving it to a child under 6 years old, make sure to teach them good brushing and rinsing habits to help prevent swallowing the medication. It's important to supervise young children until they can use it safely on their own.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 2 years of age and older use this drug?

Apply toothpaste onto a toothbrush and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What should I do if I have a child under 2 years of age?

Consult a dentist or doctor for guidance on use.

What precautions should I take for children under 6 years of age?

Instruct them in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without assistance.

What should I do if irritation occurs?

Discontinue use if irritation occurs.

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

Get medical help or contact a Poison Control Center right away.

Are there any contraindications for this drug?

No specific contraindications are mentioned.

What are the storage instructions for this drug?

Store below 25°C (77°F).

Is there any information regarding use during pregnancy or lactation?

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

Are there any known drug interactions?

No specific drug interactions are mentioned.

Packaging Info

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

Packaging configurations for The Humble Co Natural Charcoal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients, which are insert inactive ingredients here.

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

For adults and children aged 2 years and older, the recommended method of administration involves applying toothpaste onto a toothbrush. It is advised to brush teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. For children under 6 years of age, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing toothpaste. Supervision is recommended until the child is capable of brushing without assistance.

For children under 2 years of age, it is essential to consult a dentist or doctor prior to use to determine appropriate dental care practices.

Contraindications

Use is contraindicated in individuals who experience irritation upon application; in such cases, discontinue use immediately. Additionally, the product should be kept out of reach of children under 6 years of age. If more than the recommended amount for brushing is accidentally ingested, seek medical assistance or contact a Poison Control Center promptly.

Warnings and Precautions

In the event of irritation, it is imperative to discontinue use immediately. Healthcare professionals should advise patients to monitor for any signs of adverse reactions and to seek alternative treatments if necessary.

This product must be kept out of reach of children under 6 years of age to prevent accidental ingestion or misuse. It is essential to educate caregivers on the importance of proper storage to ensure the safety of young children.

In cases where more than the recommended amount used for brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center without delay. Prompt action is necessary to mitigate potential health risks associated with ingestion.

Side Effects

In clinical use, patients should be advised to discontinue use if irritation occurs. It is important to keep the product out of reach of children, particularly those under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, patients or caregivers should seek medical help or contact a Poison Control Center immediately.

No specific adverse reactions or side effects have been detailed in the available data.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 The Humble Co Natural Charcoal (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for The Humble Co Natural Charcoal.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, it is important to instruct them in proper brushing and rinsing techniques to minimize swallowing. Supervision is recommended until the child is capable of using the product without assistance.

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

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any 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 this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data provided on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

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 specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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.

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.

Additionally, healthcare providers should inform patients to discontinue use if any irritation occurs and to consult with a healthcare professional if they have concerns regarding the product's use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product below 25°C (77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from temperature fluctuations and environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents or guardians to teach children under 6 years of age proper brushing and rinsing techniques to minimize the risk of swallowing the medication. Supervision is recommended until the child is capable of using the product without assistance. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for The Humble Co Natural Charcoal, 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 Humble Co Natural Charcoal, 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.