EVERSMILE ORTHOFOAM ANTICAVITY- 0.05% sodium fluoride rinse liquid

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride....... 0.05%

(0.02% w/v fluoride ion)

Purpose

Anticavity

Uses

aids in the prevention of dental cavities

​​Warnings

​Stop use and ask 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.

​Directions:

To Brush:

Dispense 1-2 pumps of foam onto a toothbrush. Brush teeth

thoroughly, preferably after each meal or at least twice a day,

or as directed by a dentist or physician

EverSmile Traybrush application:

Adults and children 12 yrs. of age and older:

Dispense 1-2 pumps of foam onto each side of the TrayBrush.

Insert the foam-filled Traybrush into your mouth. Gently bite

up and down, and move the handle side to side for approximately 

2 minutes to clean.

If needed, remove the TrayBrush to spit out

excess foam- do not swallow, then reinsert

it immediately.

Option: after brushing keep the TrayBrush in

contact with your teeth for up to 5 minutes

to enhance the therapeutic benefits.

Use daily or as directed by your dentist.

Children under 12 years of age: consult a dentist or doctor

Other information

store at controlled room temperature 

68-77°F(20-25°)

Inactive ingredients

Water, hydrogen peroxide, PVP, PEG, glycerin, sucralose,

sodium lauryl sulfate, natural bubble gum flavor, sodium

citrate, sodium benzoate

QUESTIONS

​Questions? +​1(855)595-2999

EverSmile® ORTHOFOAM ANTICAVITY BRACES CLEANING FOAM Labelinh

------------------------------------------

EverSmile​®

​ORTHOFOAM

  ANTICAVITY

     BRACES

CLEANING FOAM

Bubble gum​

​0.05% Sodium Fluoride             50 mL (1.69 fl oz)

Manufactured By

EverBrands, Inc

11791 Monarch St

Garden Grove,

CA 92841

(855)595-2999

info@eversmilewhite.com

eversmilewhite.com

RES

INGREDIENTS AND APPEARANCE

EVERSMILE ORTHOFOAM ANTICAVITY 
0.05% sodium fluoride rinse liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72655-600
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
PVP (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72655-600-01	1 in 1 BOX	04/10/2026
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 Drug	M021	04/10/2026

Labeler - Everbrands, Inc. (080314845)

Registrant - Everbrands, Inc. (080314845)

Establishment
Name	Address	ID/FEI	Business Operations
Everbrands, Inc.		080314845	manufacture(72655-600)