ADD CONDITION

items per page

Mastic Dent Oulo Action

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
15304-4681

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 a product designed for oral care, suitable for adults and children aged 2 years and older. This product is typically used to help maintain good dental hygiene by promoting thorough brushing after meals or at least twice a day. It is important to follow the guidance of a dentist or physician, especially for children under 2 years old, to ensure safe and effective use.

While specific details about the drug's mechanism of action or additional context were not provided, the emphasis on proper brushing and rinsing habits suggests that this product plays a role in preventing dental issues by encouraging effective oral hygiene practices.

Uses

This product is suitable for both adults and children 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 proper brushing and rinsing techniques to help minimize the risk of swallowing.

For children under 2 years old, this product should only be used if directed by a dentist or physician. Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this product.

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

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

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

When using this product, it's important to stop using it if you experience any irritation. This helps ensure your safety and comfort while using the product.

Make sure to 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. Your prompt action can make a significant difference in ensuring their safety.

Overdose

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

Signs of an overdose can include unusual symptoms, so it's crucial to act quickly if you suspect an overdose has occurred. Always prioritize safety and don't hesitate to reach out for professional assistance in such 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.

Since there are no special precautions mentioned regarding the use of this medication during pregnancy, maintaining open communication with your doctor is key to ensuring both your safety and that of your baby. Always prioritize your health and seek guidance when needed.

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 are no known concerns about this product being passed into breast milk or posing any risk to your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 any specific instructions from a dentist or physician.

For children under 2 years, do not use this product unless 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

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 a healthcare provider. They can help determine the best approach 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 healthcare team are essential to ensure safety and effectiveness.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 and share any concerns you may have about your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. This helps maintain its effectiveness and prevents contamination. It's also important to protect the product from excessive heat, as high temperatures can compromise its quality.

If you open the tube but do not use the contents within a specified time frame, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and responsibly.

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 help prevent swallowing the medication, make sure to practice good brushing and rinsing habits.

FAQ

Who can use this product?

This product is intended for adults and children 2 years and older. Children under 2 years should not use it unless directed by a dentist or physician.

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. Use a pea-sized amount and practice good brushing and rinsing habits to minimize swallowing.

What should I do if irritation occurs?

If irritation occurs while using this product, you should discontinue use immediately.

What precautions should I take regarding children?

Keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than used for brushing, seek medical help or contact a poison control center right away.

Are there any contraindications for this product?

No specific contraindications are listed for this product.

Is this product safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation.

How should I store this product?

Store the product at room temperature, keep the tube tightly closed when not in use, and protect it from excessive heat.

Packaging Info

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

Packaging configurations for Mastic Dent Oulo Action.
Details

Drug Information (PDF)

This file contains official product information for Mastic Dent Oulo Action, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3 and is packaged in a box designed for toothpaste. An image of the label is available under the filename "toothpasteoulo.jpg."

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 to use as directed by a dentist or physician. Patients should be instructed in proper brushing and rinsing habits to minimize the risk of swallowing.

Use in children under 2 years is not recommended unless directed by a dentist or physician. There are no 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 recommended to monitor the patient for any adverse reactions following administration. Adjustments to the frequency of application may be made based on the patient's response and clinical judgment.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

When using this product, it is imperative to discontinue use immediately if any irritation occurs. Healthcare professionals should advise patients to monitor for signs of irritation and to seek alternative treatments if such symptoms arise.

This product must be kept out of reach of children under 6 years of age. In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is crucial to seek medical assistance or contact a poison control center without delay. This precaution is essential to ensure the safety and well-being of young children who may be at risk of adverse effects from inappropriate use.

Side Effects

Patients using this product may experience irritation. In such cases, it is advised to discontinue use immediately.

Additionally, it is important to keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than the amount typically used for brushing, medical assistance should be sought or a poison control center should be contacted without delay.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Mastic Dent Oulo Action (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mastic Dent Oulo Action.
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 to use the product as directed by a dentist or physician. Caregivers should instruct children in proper brushing and rinsing techniques 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 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 ensure that the product is kept 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.

Healthcare professionals should advise caregivers to seek immediate medical assistance or contact a poison control center if an overdose occurs. Prompt action is essential to mitigate potential risks associated with overdosage.

Monitoring for symptoms related to overdosage is important, although specific symptoms are not detailed in the provided information. Therefore, healthcare providers should remain vigilant and assess the patient for any unusual signs or reactions following an overdose.

Management of overdosage should be guided by clinical judgment and may involve supportive care as necessary. It is recommended that healthcare professionals familiarize themselves with local poison control resources to facilitate timely intervention in cases of overdosage.

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 compound in these areas.

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 that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat to ensure optimal quality. It is important to discard the product after opening if it is not used within the specified time frame.

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 Oulo Action, 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 Oulo Action, 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.