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Auraglow Whitening

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This product has been discontinued

Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, 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
November 7, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, 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
November 7, 2022
Manufacturer
Auraglow LLC
Registration number
part355
NDC root
81740-001
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

Auraglow is a whitening toothpaste designed to help improve the brightness of your smile while also providing essential dental care. It contains fluoride, which aids in the prevention of dental cavities, and 3% hydrogen peroxide, a common ingredient known for its whitening properties.

By using Auraglow, you can work towards achieving a whiter smile while also protecting your teeth from decay. This toothpaste is distributed by Auraglow LLC, ensuring a quality product for your oral hygiene routine.

Uses

You can use this product to help prevent dental cavities. It works by strengthening your teeth and making them more resistant to decay. It's important to maintain good oral hygiene alongside using this product for the best results.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or other harmful effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you have a child under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. It's also a good idea to supervise younger children while they brush until they can do it on their own.

For children under 2 years of age, it's best to consult with a dentist or doctor before starting any brushing routine. They can provide guidance tailored to your child's needs. Remember, good dental hygiene is essential for everyone!

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse or dependence associated with this product, always use it as directed to ensure your safety and well-being.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. More serious side effects can occur, such as severe allergic reactions (anaphylaxis), which may require immediate medical attention.

It's important to be aware of these potential adverse reactions. If you notice any unusual symptoms or if common side effects persist or worsen, please consult your healthcare provider for guidance.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help immediately or contact a Poison Control Center. This ensures your safety and allows for prompt assistance if needed.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this product. Always use it as directed to minimize any risks. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

There is currently no specific information available about the use of Auraglow Whitening Toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any concerns about using this product while pregnant, it’s best to consult with your healthcare provider for personalized advice. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

There is no specific information available about the use of Auraglow Whitening Toothpaste for nursing mothers or any considerations related to breastfeeding. If you are breastfeeding and have concerns about using this product, it may be a good idea to consult with your healthcare provider for personalized advice. They can help you understand any potential 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. If a child accidentally swallows more than what is typically 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, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor.

For children under 6, it's essential to teach them proper brushing and rinsing techniques to reduce the risk of swallowing the product. Always supervise younger children while they brush their teeth until they are capable of doing it on their own. If your child is under 2 years old, consult with a dentist or doctor 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 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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a measure of how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication.

For those with significant renal impairment, special monitoring is necessary to prevent potential toxicity. Always communicate with your healthcare provider about your kidney health to ensure the best treatment plan for you.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage may need to be adjusted. This means that the amount of medication you take could be different from what is typically prescribed. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests, which are tests that check how well your liver is working.

When taking this medication, caution is advised due to your liver condition. Always communicate openly with your healthcare team about your liver health to ensure safe and effective treatment.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

This medication is administered through dental use, so it's important to follow the instructions carefully. Keep it 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. It's also essential to teach children under 6 good brushing and rinsing habits to minimize swallowing, and supervise them until they can brush independently. For children under 2 years old, consult a dentist or doctor before use.

FAQ

What is Auraglow?

Auraglow is a whitening toothpaste that aids in the prevention of dental cavities.

What are the key ingredients in Auraglow?

Auraglow contains fluoride and 3% hydrogen peroxide, which help in cavity prevention.

How should I use Auraglow?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day.

What should I do if a child under 6 accidentally swallows Auraglow?

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

Are there any contraindications for using Auraglow?

No specific contraindications are listed for Auraglow.

Is Auraglow safe for use during pregnancy?

The drug insert does not provide specific information regarding the safety of Auraglow during pregnancy.

Can I use Auraglow if I have liver or kidney problems?

Patients with liver or renal impairment may require dosage adjustments and should have their function monitored.

How should I store Auraglow?

Store Auraglow at room temperature, protect it from light, and do not freeze.

What should I do if I have questions about using Auraglow?

Consult your dentist or doctor for any questions regarding the use of Auraglow.

Packaging Info

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

Packaging configurations for Auraglow Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Auraglow Whitening Toothpaste is formulated with active ingredients including fluoride and 3% hydrogen peroxide. This toothpaste is designed to promote oral health while providing whitening benefits. It is presented in a wintergreen flavor, enhancing the user experience. The product has a net weight of 4.0 oz (113 g) and is distributed by Auraglow LLC, located in Stamford, CT 06901.

Uses and Indications

This drug is indicated for the prevention of dental cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing. Healthcare professionals should advise caregivers to supervise children as necessary until they are capable of brushing without assistance. For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of the patient.

Currently, there are no specific warnings or general precautions outlined for the use of this product. Additionally, no laboratory tests have been recommended for monitoring during its use. Healthcare professionals should remain vigilant and exercise clinical judgment when advising patients on the safe use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions should be communicated to patients to ensure they are aware of potential side effects and can report any concerning symptoms promptly.

In addition to the common and serious adverse reactions, there are additional adverse reactions that have been noted in postmarketing experiences. These reactions may not have been fully characterized during clinical trials and warrant further investigation and reporting.

Healthcare professionals should remain vigilant in monitoring for these adverse reactions and provide appropriate guidance to patients regarding the management of any side effects experienced during treatment.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Auraglow Whitening.
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 recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor 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.

Pregnancy

There is no specific information regarding the use of Auraglow Whitening Toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There is no specific information regarding the use of Auraglow Whitening Toothpaste in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the absence of data when advising lactating mothers about the use of this product. The effects on breastfed infants have not been studied, and the potential for excretion in breast milk is unknown.

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in this patient population. Regular renal function tests are recommended for patients with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to assess the impact of the drug on liver health. Caution should be exercised when administering the drug to patients with liver dysfunction, ensuring that any potential risks are carefully weighed against the benefits of treatment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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. It is important to emphasize the potential risks associated with misuse. 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. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

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 protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount is swallowed, immediate medical assistance or contact with a Poison Control Center is advised. It is important to instruct children under 6 in proper brushing and rinsing techniques to minimize swallowing, and to supervise their use until they are capable of using the product independently. For children under 2 years of age, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Auraglow 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 Auraglow 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.