Aquafresh Whitening

Description

Aquafresh® Whitening is a fluoride toothpaste formulated for triple protection® of oral health. The product features a new formula designed to deliver a white and shine effect, promoting brighter teeth in just one week, as clinically proven. It provides lasting whitening benefits while ensuring protection for a healthy mouth. The net weight of the product is 121.9 grams (4.3 ounces). Aquafresh® is manufactured in the United States by GlaxoSmithKline LLC, located in East Durham, NY 12423. The Aquafresh® trademark is owned by the GlaxoSmithKline group of companies. The National Drug Code (NDC) for this product is 0135-0613-01.

Uses and Indications

Aquafresh White & Shine is indicated for the enhancement of tooth brightness and whiteness. Clinical studies have demonstrated that this product helps maintain whiter and brighter teeth for an extended duration. Regular use of Aquafresh White & Shine, in conjunction with standard brushing practices, is associated with achieving visibly brighter teeth within one week compared to the use of a standard toothpaste.

There are no reported teratogenic or nonteratogenic effects associated with the use of this product.

Dosage and Administration

Healthcare professionals are advised to instruct patients to brush their teeth twice daily, with a maximum frequency of three times per day. It is essential that patients avoid swallowing the product during use. After brushing, patients should spit out the product to ensure proper administration and minimize ingestion.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

It is imperative to adhere strictly to the product label when using this toothpaste. The formulation is not recommended for use in children under 7 years of age due to safety concerns.

As with any dental product, if irritation or any adverse reaction occurs, the use of the toothpaste should be discontinued immediately. In such cases, it is advisable to consult a dentist, particularly if the patient is concurrently using fluoride supplements, to ensure appropriate dental care and management.

Storage conditions must be observed to maintain product efficacy; the toothpaste should be stored below 30°C. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this toothpaste. It is important to follow the labeling instructions carefully, particularly the warning against use in children under 7 years of age.

In clinical practice, as with other toothpastes, it is advised to discontinue use if any irritation or adverse reaction occurs. Patients are encouraged to consult a dentist if they are using fluoride supplements concurrently, as this may influence the safety and efficacy of the product.

Monitoring for these reactions is essential to ensure patient safety and to address any concerns that may arise during the use of the product.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 7 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and caution is advised when considering treatment options for younger children.

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 is no specific information regarding the use of Aquafresh Whitening Intense White and Aquafresh Whitening White and Shine during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending these products to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when discussing the use of these products during pregnancy.

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.

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 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 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 effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment and follow-up care.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It must be stored at temperatures below 30°C to maintain its efficacy. Additionally, it is essential to keep the product out of reach of children to prevent accidental ingestion or misuse. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to adhere strictly to the labeling instructions and to avoid use in children under 7 years of age. As with other toothpastes, patients should discontinue use if any irritation or adverse reactions occur and consult a dentist if they are using fluoride supplements.

Drug Information (PDF)

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

View product document (PDF)