EVERSMILE ALIGNERFRESH ENAMEL GUARD- sodium fluoride rinse 
Everbrands, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM

DRUG FACTS

Purpose

Anticavity

Active ingredient

Sodium fluoride 0.05%

(0.0225% w/v fluoride ion)

Uses

Warnings

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

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.

Directions:

Tray application

To rinse:

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

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

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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EVERSMILE ALIGNERFRESH ENAMEL GUARD 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72655-300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.225 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72655-300-011 in 1 PACKAGE02/16/2022
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/16/2022
Labeler - Everbrands, Inc. (080314845)
Registrant - Everbrands, Inc. (080314845)
Establishment
NameAddressID/FEIBusiness Operations
Everbrands, Inc.080314845manufacture(72655-300)

Revised: 3/2022
Document Id: 95469211-c4c5-4f37-9bfe-8afb6fa2b3b4
Set id: 7b3d0114-dac0-4370-8545-922ec018018e
Version: 1
Effective Time: 20220329
 
Everbrands, Inc.