PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH- sodium fluoride mouthwash 
AKG Innovations LLC

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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PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH

Drug Facts

Active ingredient

Sodium fluoride 0.02%

Purpose

Anticavity

Uses

■Aids in the prevention of dental cavities

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

Inactive ingredients

WATER, XYLITOL,

GLYCERIN, SORBITOL, PEG-40 HYDROGENATED

CASTOR OIL, FLAVOR, MENTHOL, HYDROGEN PEROXIDE,

POTASSIUM SORBATE, SODIUM BENZOATE, SODIUM

SACCHARIN, ASCORBIC ACID, SALVADORA PERSICA

BARK/ROOT EXTRACT, ZINC LACTATE.

Other information

■Store at room temperature.

Questions?

Call Customer Service-toll-free

1.855.333.2544 or visit

www.arthurglosmandentalbeauty.com

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH with Fluoride (62111-0212-4)

advanced dental

health + beauty

Arthur Glosman DDS

Beverly Hills

PROFESSIONAL

WHITENING SYSTEM

WHITENING

MOUTH WASH

with Fluoride

7.4 fl. oz. / 220 mL

Active ingredient              Purpose

SODIUM FLUORIDE 0.02% Anticavity

With Hydrogen Peroxide to help whiten

teeth; a refreshing mint flavor; menthol

for a cooling sensation; and Salvadora

Persica also known as nature’s tooth

brush.

Important:

■Read directions on carton for proper

use.

Directions for use:

■Use twice daily after brushing, with

Dr. Glosman’s WHITENING TOOTHPASTE

■vigorously swish 10 ml, (2 teaspoons)

between the teeth for 1 minute and

then spit out.

■Do not swallow.

Distributed by:

AKG Innovations, LLC

450 N. Roxbury Drive

Suite 222

Beverly Hills, CA 90210

Made in USA

A refreshing, mint flavoredwash, specially formulated with Hydrogen Peroxide for a healthier looking, whiter smile, menthol to cool the mouth and Salvadora Persica, also known as nature’s tooth brush. When used in conjunction with twice daily, regular brushing and flossing, this refreshing wash helps promote good oral hygiene.

The Dr. Glosman Dental Beauty line contains dental products as well as skin treatments:

Professional Whitening System with Refills

Professional Whitening Pen

Whitening Toothpaste with Fluoride

Whitening Mouth Wash with Fluoride

Slim Sonic Tooth Brush

Moisturizing Lip Balm

Lip Enhancer Gloss

Lip Area Rescue Treatment

MouthWashBottle

MouthWashCarton

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62111-0212
Route of Administrationoral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
CASTOR OIL (UNII: D5340Y2I9G)  
MENTHOL (UNII: L7T10EIP3A)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SALVADORA PERSICA ROOT (UNII: 526M7ZU616)  
ZINC LACTATE (UNII: 2GXR25858Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62111-0212-4220 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/14/2014
Labeler - AKG Innovations LLC (056576137)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development LLC962452533manufacture(62111-0212)

Revised: 2/2014
Document Id: 31539b3c-ad6e-4c7f-b464-2c5ed6daa711
Set id: 86d82d94-9439-4272-8ec2-8a014496d1bf
Version: 1
Effective Time: 20140214
 
AKG Innovations LLC