EVERSMILE ALIGNERFRESH ENAMEL GUARD- sodium fluoride rinse

EverSmile AlignerFresh Enamel Guard by

Drug Labeling and Warnings

EverSmile AlignerFresh Enamel Guard by is a Otc medication manufactured, distributed, or labeled by Everbrands, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

PURPOSE

Purpose

Anticavity

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​

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

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
info@eversmilewhite.com
www.eversmilewhite.com

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INGREDIENTS AND APPEARANCE

EVERSMILE ALIGNERFRESH ENAMEL GUARD 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72655-300
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.225 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETIDRONIC ACID (UNII: M2F465ROXU)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72655-300-01	1 in 1 PACKAGE	02/16/2022
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/16/2022

Labeler - Everbrands, Inc. (080314845)

Registrant - Everbrands, Inc. (080314845)

Establishment
Name	Address	ID/FEI	Business Operations
Everbrands, Inc.		080314845	manufacture(72655-300)