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Bio Spectra

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Active ingredient
Sodium Fluoride 0.243 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 2021
Label revision date
December 2, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 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 2021
Label revision date
December 2, 2024
Manufacturer
9055-7588 Québec Inc. DBA Attitude
Registration number
M021
NDC root
61649-723
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

ATTITUDE® natural care toothpaste is a vegan toothpaste that contains fluoride, designed to help maintain your oral health. It comes in a refreshing blueberry flavor and is packaged in a 120 g (4.2 oz) tube. This toothpaste is formulated to prevent, fight, and protect against cavities and tooth decay, providing effective fluoride protection. It also helps protect your teeth from acid erosion and penetrates tooth enamel to assist in rebuilding weak spots, making it a great choice for those looking for a natural care option for their dental hygiene.

Uses

You can rely on this product to help keep your teeth healthy and strong. It prevents, fights, and protects against cavities and tooth decay, ensuring that your smile stays bright. With effective fluoride protection, it works to shield your teeth from harmful acids that can cause erosion.

Additionally, this product penetrates tooth enamel, which is the hard outer layer of your teeth, to help rebuild weak spots. This means that not only does it protect your teeth, but it also actively works to strengthen them over time.

Dosage and Administration

To use this medication effectively, make sure you do not swallow it. It’s important to incorporate this product into a complete oral health routine, which includes regular flossing and dental check-ups. You should brush your teeth thoroughly for at least one minute, twice a day—ideally after each meal—or follow your dentist's instructions.

If you have children under 6 years old, use only a pea-sized amount for them and supervise their brushing to ensure they do it correctly and do not swallow the product. Additionally, if you are considering using this medication for a child under 2 years old, consult with a dentist or healthcare professional first to ensure it’s safe.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, you should call a poison control center or seek medical help immediately.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always prioritize your safety and follow the guidance provided by your healthcare professional.

Side Effects

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should contact a poison control center or seek medical help immediately.

Please be aware that there are potential side effects associated with this medication. If you experience any unusual symptoms, it's advisable to consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, you should call a poison control center or seek medical help immediately.

Always be cautious when using this medication. If you experience any unusual symptoms or reactions, stop using it and contact your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to seek help if needed.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Call a poison control center or seek medical help immediately. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication.

Remember, getting prompt assistance can make a significant difference in managing an overdose. Always prioritize safety and don’t hesitate to reach out for help if you suspect an overdose has occurred.

Pregnancy Use

When it comes to using this product during pregnancy, there are no specific guidelines or safety concerns provided. This means that there is no detailed information about whether you should adjust the dosage or take any special precautions 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 or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

When using this product for children, it's important to take special precautions. For kids under 6 years old, you should only use a pea-sized amount and supervise them while brushing to ensure they do it correctly and don’t swallow any. If your child is under 2 years old, it's best to consult with a dentist or healthcare professional before using the product. This will help ensure their safety and proper 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 considering this medication, it’s important to consult with a healthcare provider. 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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 specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, which is between 15 and 30 degrees Celsius (59 to 86 degrees Fahrenheit). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands or gloves to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

This medication is administered through the dental route, meaning it is used in your mouth. It's important to follow some guidelines for safe and effective use. Do not swallow the medication. Instead, incorporate it into your oral health routine, which should include regular flossing and dental check-ups. Brush your teeth thoroughly for at least one minute, twice a day, ideally after each meal, or as your dentist advises.

If you have children under 6 years old, use only a pea-sized amount and supervise them to ensure they brush properly and do not swallow the product. Additionally, consult a dentist or healthcare professional before using this medication for children under 2 years of age.

FAQ

What is ATTITUDE® natural care toothpaste?

ATTITUDE® natural care toothpaste is a vegan toothpaste that contains fluoride and is designed to prevent cavities and tooth decay.

How should I use ATTITUDE® natural care toothpaste?

You should brush your teeth thoroughly for at least 1 minute twice a day, preferably after each meal, and use it as part of an oral health program that includes regular flossing and dental check-ups.

Is there a specific amount of toothpaste recommended for children?

Children under 6 years of age should use only a pea-sized amount of toothpaste and should be supervised to ensure they do not swallow it.

What should I do if I accidentally swallow the toothpaste?

If swallowed, you should call a poison control center or get medical help right away.

Are there any contraindications for using this toothpaste?

No specific contraindications are listed for ATTITUDE® natural care toothpaste.

Can I use this toothpaste during pregnancy or while nursing?

There are no specific statements regarding the use of this product during pregnancy or nursing.

What are the key benefits of using ATTITUDE® natural care toothpaste?

This toothpaste effectively protects against cavities, fights tooth decay, protects teeth from acid erosion, and helps rebuild weak spots in tooth enamel.

How should I store ATTITUDE® natural care toothpaste?

Store the toothpaste at room temperature, between 15-30 °C.

Packaging Info

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

Packaging configurations for Bio Spectra.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

ATTITUDE® natural care with fluoride toothpaste BLUEBERRY little leaves is a vegan formulation designed for oral hygiene. Each tube contains 120 grams (4.2 ounces) of product. The toothpaste is identified by the Natural Product Number (NPN) 80104880, indicating its compliance with regulatory standards for natural health products.

Uses and Indications

This drug is indicated for the prevention and treatment of dental caries (cavities) and tooth decay. It provides effective fluoride protection, which aids in the remineralization of tooth enamel and helps to rebuild weak spots in the enamel structure. Additionally, this drug protects teeth from acid erosion, contributing to overall dental health.

Dosage and Administration

The product is intended for use as part of a comprehensive oral health program that includes regular flossing and dental check-ups. It is recommended that healthcare professionals instruct patients to brush their teeth thoroughly for a minimum of 1 minute, twice daily, preferably after each meal, or as directed by a dentist.

For children under 6 years of age, a pea-sized amount of the product should be used, and they must be supervised to ensure proper brushing technique and to prevent swallowing. It is essential to consult a dentist or healthcare professional prior to use in children under 2 years of age.

Patients should be advised not to swallow the product during use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a poison control center if the product is swallowed.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, immediate action is required. Healthcare professionals should advise patients or caregivers to contact a poison control center or seek medical assistance without delay.

Monitoring for potential adverse effects is essential to ensure patient safety. Regular assessments and appropriate laboratory tests may be necessary, depending on the specific medication and patient condition.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, it is imperative to contact a poison control center or seek medical assistance immediately.

Drug Interactions

There are no specific drug interactions identified for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Packaging configurations for Bio Spectra.
Details

Pediatric Use

Pediatric patients under 6 years of age should use only a pea-sized amount of the product, and supervision is recommended to ensure proper brushing techniques and to prevent swallowing. For children under 2 years of age, it is advised to consult a dentist or healthcare professional prior to use.

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 are no specific statements regarding the use of this product during pregnancy, including any safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and 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 lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further data may be necessary to inform clinical decisions.

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 an overdosage, immediate action is crucial. If the substance is ingested, it is imperative to contact a poison control center or seek medical assistance without delay.

Healthcare professionals should be aware that prompt intervention can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any symptoms presented. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance involved and the severity of the overdosage.

In all cases, the guidance of a poison control center can provide critical information for the appropriate management of the situation.

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 medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to call a poison control center or seek medical assistance immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

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 at room temperature, maintaining a temperature range of 15 to 30 °C. Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered via the dental route. Patients should be counseled not to swallow the product and to incorporate it into a comprehensive oral health program that includes regular flossing and dental check-ups. It is recommended that patients brush their teeth thoroughly for at least one minute twice a day, ideally after each meal, or as directed by a dentist. For children under 6 years of age, only a pea-sized amount should be used, and they should be supervised to ensure proper brushing and to prevent swallowing. Additionally, consultation with a dentist or healthcare professional is advised before use in children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Bio Spectra, 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 Bio Spectra, 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.