Auraglow Daily

Description

Auraglow is a daily toothpaste formulated to strengthen teeth and prevent cavities. It contains fluoride as an active ingredient and is flavored with wintergreen. The product is packaged in a net weight of 4.0 ounces (113 grams). Auraglow is distributed by Auraglow LLC, located in Stamford, CT 06901.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in strengthening teeth and effectively prevents the formation of 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 daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until the child is capable of brushing without assistance.

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

Healthcare professionals should remain vigilant and advise patients to adhere strictly to the recommended usage guidelines to prevent any potential adverse effects associated with misuse.

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 were noted with varying frequencies, and healthcare providers should be vigilant in assessing patients for these effects.

In addition to the common adverse reactions, there are other important notes regarding additional adverse reactions that may arise during postmarketing surveillance. These experiences highlight the need for ongoing evaluation of the medication's safety profile in a broader patient population.

Healthcare professionals are encouraged to report any serious adverse reactions to ensure comprehensive safety monitoring and to facilitate the understanding of the medication's risk-benefit profile.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

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 of age 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 infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

There is no specific information regarding the use of Auraglow Daily sodium fluoride paste, dentifrice in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in geriatric populations, as individual patient factors may influence treatment decisions. Regular monitoring and assessment of the patient's response to therapy are recommended to ensure safety and efficacy.

Pregnancy

There is no specific information regarding the use of Auraglow Daily (sodium fluoride paste, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the absence of data when assessing the potential risks and benefits for pregnant patients.

Lactation

There is no specific information regarding the use of Auraglow Daily sodium fluoride paste, dentifrice in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to regularly monitor the renal function of these patients to ensure safe and effective treatment. Assessment of creatinine clearance is critical in determining the appropriate dosing regimen. Additionally, special considerations should be taken into account for patients with severe renal impairment to mitigate potential risks associated with therapy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 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 preventing adverse effects.

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, and must not be frozen. To ensure optimal quality, any unused product should be discarded after opening if it is not used within the specified time frame.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents to teach children under 6 years of age proper brushing and rinsing habits to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

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

View product document (PDF)