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Safetymaxx Mint Flavor

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
November 15, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
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 2011
Label revision date
November 15, 2011
Manufacturer
FSi, Inc.
Registration number
part355
NDC root
60371-344
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

SafetyMaxx Toothgel is a dental product designed to help protect your teeth against cavities. By using this toothgel, you can support your oral health and maintain a brighter smile. It's an easy addition to your daily dental care routine, ensuring that your teeth stay strong and healthy.

Uses

You can use this product to help protect against cavities, which are holes in your teeth caused by decay. By incorporating it into your dental care routine, you can support your oral health and reduce the risk of developing cavities. There are no known teratogenic effects (harmful effects on a developing fetus) or nonteratogenic effects associated with this product, making it a safe option for most users.

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 6 years and older. If you're helping a child between the ages of 2 and 6, use only a pea-sized amount of toothpaste and supervise their brushing and rinsing to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before using any toothpaste. This ensures that you’re taking the right steps for their dental care. Remember, good oral hygiene is essential for everyone!

What to Avoid

It's important to keep this medication out of reach of children under 6 years of age to ensure their safety. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use medications responsibly and as directed. If you have any questions or concerns about this medication, consult your healthcare provider for guidance.

Side Effects

If you accidentally swallow more than the recommended amount of this product, it's important to seek medical help or contact a Poison Control Center right away. This is especially crucial for children, as the product should be kept out of reach of those under 6 years of age to prevent any potential harm. Always use this product as directed to ensure safety.

Warnings and Precautions

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 right away. This is crucial to ensure your safety and well-being.

Additionally, please keep this product out of reach of children under 6 years old to prevent any accidental ingestion. Always prioritize safety by using this product as directed.

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 right away. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for assistance. Your safety is the priority.

Pregnancy Use

Currently, there is no available information about the use of SafetyMAXX Mint Flavor - sodium fluoride gel, dentifrice during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is 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 are no particular considerations or precautions mentioned that you need to be aware of related to breastfeeding. This means that, based on the available information, you can use the product without concern for its effects on your milk production or your nursing infant.

Pediatric Use

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

If your child is between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to help prevent swallowing. For children under 2 years, it's best to consult with a dentist or physician before use.

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

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 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 or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. Avoid freezing, as this can damage the product. Once you open it, be sure to discard any unused portions to maintain safety and effectiveness. Remember that the product has a shelf life of 2 years from the date of manufacture, so check the expiration date to ensure you are using it within this timeframe.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is SafetyMaxx Toothgel used for?

SafetyMaxx Toothgel helps protect against cavities.

What age groups can use SafetyMaxx Toothgel?

Adults and children 6 years of age and older can use it. For children 2 to 6 years, use only a pea-sized amount and supervise brushing.

What should I do if a child under 2 years needs to use SafetyMaxx Toothgel?

You should ask a dentist or physician before using it for children under 2 years.

Are there any contraindications for SafetyMaxx Toothgel?

No contraindications are specified in the provided information.

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

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

How should SafetyMaxx Toothgel be stored?

Store SafetyMaxx Toothgel at room temperature, do not freeze, and discard after opening. It expires 2 years from the date of manufacture.

Is SafetyMaxx Toothgel safe to use during pregnancy or while nursing?

There is no specific information regarding safety concerns or recommendations for use during pregnancy or lactation.

Are there any known drug interactions with SafetyMaxx Toothgel?

No drug interactions are mentioned in the provided information.

What is the recommended usage for adults and children over 6?

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.

What precautions should be taken for children under 6 years?

Keep SafetyMaxx Toothgel out of reach of children under 6 years of age.

Packaging Info

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

Packaging configurations for Safetymaxx Mint Flavor.
Details

Drug Information (PDF)

This file contains official product information for Safetymaxx Mint Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

SafetyMaxx Toothgel is a dental care product formulated for oral hygiene. It is designed to provide effective cleaning and protection for teeth and gums. The product is presented in a gel dosage form, which facilitates easy application and distribution within the oral cavity. The specific formulation details, including active and inactive ingredients, contribute to its efficacy in promoting dental health.

Uses and Indications

This drug is indicated for the protection against dental cavities.

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

Dosage and Administration

Adults and children aged 6 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

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

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

In the event that more than the recommended amount for brushing is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay. This precaution is essential to ensure the safety and well-being of the individual.

Additionally, it is crucial to keep this product out of the reach of children under 6 years of age. Proper storage and handling are necessary to prevent accidental ingestion, which could lead to serious health risks. Healthcare professionals should advise caregivers on the importance of safeguarding this product to minimize potential hazards.

Side Effects

In clinical use, it is important to note that if more than the recommended amount for brushing is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. This warning underscores the potential risks associated with improper use of the product.

Additionally, it is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion and potential adverse effects. This precaution is essential to ensure the safety of young children who may be at greater risk of harm from misuse.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Safetymaxx Mint Flavor.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 6 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.

For 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. In children under 2 years of age, consultation with a dentist or physician is advised before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of SafetyMAXX Mint Flavor - sodium fluoride gel, dentifrice during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential risks and benefits of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation or breastfeeding.

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 patient's overall health status and liver function.

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 ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and therefore, a thorough assessment of the patient's condition is necessary.

Management procedures should include monitoring the patient for any adverse effects and providing supportive care as needed. It is advisable to have the product label and any relevant information available when contacting medical professionals or poison control for guidance on further management steps.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available for the product associated with SPL code 90375-7.

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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is not exposed to freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy. The expiration date is set at two years from the date of manufacture, and it is crucial to adhere to this timeline for optimal use.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Safetymaxx Mint Flavor, 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 Safetymaxx Mint Flavor, 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

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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.