Drugplain

EverSmile AlignerFresh Enamel Guard .225 mg/mL

SODIUM FLUORIDE · RINSE · Everbrands, Inc.

No Recall HistoryCurrently in Shortage
Plain English

EverSmile AlignerFresh Enamel Guard is a rinse containing sodium fluoride at .225 mg/mL, taken oral. Manufactured by Everbrands, Inc..

Key Facts

Brand Name
EverSmile AlignerFresh Enamel Guard
Generic Name
SODIUM FLUORIDE
NDC Code (Product)
72655-300
Manufacturer
Everbrands, Inc.
Strength
.225 mg/mL
Dosage Form
RINSE
Route
ORAL
Marketing Status
Application #
M022
Marketing Start
02/16/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses aids in prevention of dental cavities

Dosage & Administration

Directions: Tray application Adults and children 12 yrs. of age and older: Dispense up to a full pump of foam inside each tray. Use the nozzle tip to cover all areas of the tray evenly with foam. Place form-filled trays back in mouth. Spit out excess. No need to rinse as foam naturally dissipates. Do not swallow rinse. Children under 12 years of age: consult a dentist or doctor. To rinse: Adults and children 12 years & older: Use twice a day after brushing your teeth with a toothpaste. Vigorously swish 2 pumps of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 12 years of age: consult a dentist or doctor.

Warnings

Warnings Stop use and ask a dentist if oral irritation or tooth sensitivity occurs ​

Frequently Asked Questions

What is EverSmile AlignerFresh Enamel Guard used for?

EverSmile AlignerFresh Enamel Guard contains SODIUM FLUORIDE. It is a rinse taken oral. Consult your doctor for specific uses.

Is EverSmile AlignerFresh Enamel Guard a controlled substance?

EverSmile AlignerFresh Enamel Guard is not classified as a controlled substance by the DEA.

What is the generic name for EverSmile AlignerFresh Enamel Guard?

The generic name for EverSmile AlignerFresh Enamel Guard is SODIUM FLUORIDE. There are 11 other brand versions of SODIUM FLUORIDE.

What is the NDC code for EverSmile AlignerFresh Enamel Guard .225 mg/mL?

The NDC (National Drug Code) for EverSmile AlignerFresh Enamel Guard .225 mg/mL is 72655-300, listed by Everbrands, Inc..