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Mastic Dent Whitening

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 2.2 mg/1 mL
Other brand names
Dosage form
Paste, Dentifrice
Routes
  • Dental
  • Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2005
Label revision date
December 26, 2012
Active ingredient
Sodium Fluoride 2.2 mg/1 mL
Other brand names
Dosage form
Paste, Dentifrice
Routes
  • Dental
  • Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2005
Label revision date
December 26, 2012
Manufacturer
Chia Gi LTD
Registration number
part355
NDC root
15304-4182

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 toothpaste product designed for adults and children aged 2 years and older. This toothpaste is intended to help maintain oral hygiene by promoting thorough brushing after meals or at least twice a day, as recommended by a dentist or physician.

While specific details about the active ingredients or mechanisms of action are not provided, using toothpaste regularly is essential for good dental health. It helps to remove food particles and plaque, which can lead to cavities and gum disease if not properly managed.

Uses

You can use this product for maintaining oral hygiene if you are an adult or a child aged 2 years and older. It's important to brush your teeth thoroughly after meals or at least twice a day, following the guidance of your dentist or physician. Additionally, you should be instructed on good brushing and rinsing habits to help minimize the risk of swallowing the product.

If you have a child under 2 years old, do not use this product unless directed by a dentist or physician. There are no specific teratogenic (causing birth defects) or nonteratogenic effects mentioned, so you can feel assured about its safety in that regard.

Dosage and Administration

When using this medication, you should apply a pea-sized amount. This small quantity is typically enough to ensure effective treatment. Make sure to follow any additional instructions provided by your healthcare professional regarding how often to use it. Always remember that using more than the recommended amount does not necessarily lead to better results and could cause unwanted side effects.

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

When using this product, you may experience irritation. If this happens, it's important to 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.

Warnings and Precautions

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 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.

In case of accidental swallowing of a larger amount, you should also get emergency medical assistance or reach out to a poison control center immediately. Your safety is a priority, so please take these precautions seriously.

Overdose

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, you should seek medical help or contact a poison control center immediately.

Signs of an overdose can vary, but if you notice unusual symptoms or if someone has ingested too much, don't hesitate to get help right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Currently, there are no special precautions mentioned regarding the use of this medication during pregnancy, but staying informed and discussing any concerns with your doctor is essential for your well-being and that of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

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 the amount used for brushing, seek medical help or contact a poison control center immediately. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly after meals or at least twice a day, following the guidance of a dentist or physician.

For children under 2 years, do not use this product unless specifically directed by a dentist or physician. Additionally, teaching your child good brushing and rinsing habits can help minimize the risk of swallowing the product.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 (liver issues).

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 important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, remember to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally or use it for dental purposes. It's important to brush your teeth thoroughly after meals or at least twice a day, following any specific instructions given by your dentist or physician.

To ensure safety, make sure to practice good brushing and rinsing habits to minimize the chance of swallowing the medication. If you have any questions or need further guidance, don't hesitate to reach out to your healthcare provider.

FAQ

Who can use this product?

This product is intended for adults and children 2 years and older.

How should I use this product?

You should brush thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.

What should I do if I accidentally swallow more than the recommended amount?

If you accidentally swallow more than used for brushing, get medical help or contact a poison control center right away.

Are there any age restrictions for this product?

Children under 2 years should not use this product unless directed by a dentist or physician.

What precautions should I take when using this product?

Keep this product out of reach of children under 6 years of age, and discontinue use if irritation occurs.

How should I store this product?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Is there any specific information regarding use during pregnancy or nursing?

There are no specific warnings or recommendations regarding use during pregnancy or by nursing mothers.

What amount of product should I use?

You should use a pea-sized amount of the product.

Packaging Info

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

Packaging configurations for Mastic Dent Whitening.
Details

Drug Information (PDF)

This file contains official product information for Mastic Dent Whitening, 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 use in adults and children aged 2 years and older. It is recommended to brush thoroughly after meals or at least twice a day, or as directed by a dentist or physician. Patients should be instructed in proper brushing and rinsing habits to minimize the risk of swallowing.

Use of this drug is not recommended for children under 2 years of age unless directed by a dentist or physician. There are no specific teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to administer a pea-sized amount of the product. This dosage should be applied as needed, ensuring that the application site is clean and dry prior to use. It is important to monitor the patient’s response to the treatment and adjust the frequency of application accordingly, based on clinical judgment and 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. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

When using this product, it is imperative to discontinue use immediately if any irritation occurs. This precaution is essential to prevent further complications or adverse reactions.

This product must be kept out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than what is typically used for brushing, it is crucial to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be vigilant in advising patients about the importance of these warnings to ensure safe usage and to mitigate potential risks associated with accidental ingestion.

Side Effects

Patients using this product should be aware of potential adverse reactions. In the event of irritation, it is advised to discontinue use immediately. Additionally, the product should be kept out of reach of children under 6 years of age. If a child accidentally swallows more than the amount intended for brushing, it is crucial to seek medical assistance or contact a poison control center without delay. These precautions are essential to ensure the safety and well-being of all users.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Mastic Dent Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mastic Dent Whitening.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event of accidental ingestion of more than the amount used for brushing, immediate medical assistance or contact with a poison control center is advised.

For children aged 2 years and older, it is recommended to brush thoroughly after meals or at least twice a day, or as directed by a dentist or physician. Proper instruction in good brushing and rinsing habits is essential to minimize the risk of swallowing.

The product is not recommended for use in children under 2 years of age unless directed by a dentist or physician.

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

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

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

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 overdosage, it is crucial to keep the product out of reach of children under 6 years of age. Accidental ingestion of amounts exceeding the recommended dosage for brushing may lead to adverse effects.

Recommended Actions If an overdose occurs, it is imperative to seek medical assistance immediately or contact a poison control center for guidance. Prompt action is essential to mitigate potential health risks associated with overdosage.

Potential Symptoms While specific symptoms of overdosage are not detailed, any unusual reactions following excessive ingestion should be treated seriously, and medical advice should be sought without delay.

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

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 ensure that patients understand the necessity of proper storage to prevent such incidents.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It should be stored at room temperature, away from direct light exposure to maintain its quality. It is essential to avoid freezing the product, as this may compromise its effectiveness. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should be instructed to administer the product orally or dentally, brushing thoroughly after meals or at least twice a day, or as directed by a dentist or physician. Clinicians should emphasize the importance of good brushing and rinsing habits to minimize swallowing. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mastic Dent Whitening, 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 Mastic Dent Whitening, 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.