Eversmile Alignerfresh Enamel Guard Rinse
FDA Label NDC 72655-300

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everbrands, Inc. for the product Eversmile Alignerfresh Enamel Guard (NDC 72655-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Otc - Purpose

Purpose

Anticavity

Otc - Active Ingredient

Active ingredient

Sodium fluoride 0.05%

(0.0225% w/v fluoride ion)

Indications & Usage

Uses

  • aids in prevention of dental cavities

Warnings

Warnings

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If more than used for rinsing is accidentally

swallowed, get medical help or contact a poison Control Center right away.

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.

Other Safety Information

Other Information store at controlled room temperature 68-77°F (20 - 25°C)

Inactive Ingredient

Inactive Ingredients:
Etidronic Acid, glycerin, hydrogen peroxide,
menthe arvensis oil, PEG, PVP, sodium
benzoate, sodium citrate, sodium lauryl sulfate.
sucralose, water

Otc - Questions

Questions?  +1 (855) 595-2999

Package Label

EverSmile®

ALIGNERFRESH

ENAMEL
GUARD

FLUORIDE FOAM

50 mL (1.69fl oz)

Manufactured By
EverBrands, Inc. 401 N Oak St.
Inglewood, CA 90302

855 595-2999
[email protected]
www.eversmilewhite.com

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