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  5. Label Information: Eversmile Alignerfresh Enamel Guard

FDA Label for Eversmile Alignerfresh Enamel Guard

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. OTC - ACTIVE INGREDIENT
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. OTHER SAFETY INFORMATION
    9. INACTIVE INGREDIENT
    10. OTC - QUESTIONS
    11. PACKAGE LABEL

Eversmile Alignerfresh Enamel Guard Product Label

The following document was submitted to the FDA by the labeler of this product Everbrands, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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