PROFESSIONAL WHITENING SYSTEM WHITENING- sodium fluoride paste 
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 TOOTHPASTE with Fluoride

PROFESSIONALWHITENING SYSTEM WHITENINGTOOTHPASTE with Fluoride

Active Ingredient

SODIUM FLUORIDE 0.23%...

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Supervise children as necessary until capable of using without supervision.

■ Adults and children 6 years of age and older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a

dentist or physician.

■ Children under 12 years, instruct in good brushing and rinsing habits (to minimize swallowing).

■ Children under 6 years, do not use unless directed by a dentist or physician.

Inactive Ingredients

WATER, SORBITOL, HYDRATED SILICA, GLYCERIN, XYLITOL, FLAVOR,

CELLULOSE GUM, SODIUM LAUROYL SARCOSINATE, SODIUM SACCHARIN, CARRAGEENAN, TITANIUM DIOXIDE,

HYDROGEN PEROXIDE, MENTHOL, SALVADORA PERSICA BARK/ROOT EXTRACT.

Questions or comments:

Call Customer Service-toll free

1-855-333-2544 or visit www.arthurglosmandentalbeauty.com

PROFESSIONALWHITENING SYSTEM WHITENINGTOOTHPASTE with Fluoride 113.6 g (62111-0213-2)

advanced dental

health +beauty

ARTHUR GLOSMAN DDS

Beverly Hills

PROFESSIONAL

WHITENING SYSTEM

WHITENING

TOOTHPASTE

with Fluoride

Net Wt. 4.2 oz. / 113.6 g

A refreshing, peppermint flavored toothpaste, formulated with Hydrogen Peroxide for a healthier looking, whiter smile, silica tohelp remove surface stains, menthol to cool and Salvadora Persica, also known as nature’s tooth brush. When used in conjunctionwith twice daily flossing and rinsing with Whitening Mouth Wash this invigorating toothpaste 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

Important:

Read directions on

carton for proper use.

Distributed by:

AKG Innovations, LLC

450 N. Roxbury Drive

Suite 222

Beverly Hills, CA 90210

Made in USA #90215


OuterLabel

InnerLabel

PROFESSIONAL WHITENING SYSTEM WHITENING 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62111-0213
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.23 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
MENTHOL (UNII: L7T10EIP3A)  
SALVADORA PERSICA ROOT (UNII: 526M7ZU616)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62111-0213-21 in 1 PACKAGE
1113.6 g in 1 TUBE
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(62111-0213)

Revised: 2/2014
Document Id: 7a426e80-7e89-4f1e-8c92-0c6c09abd0ac
Set id: b208dc26-c3ec-4325-bfb9-af1984236a28
Version: 1
Effective Time: 20140214
 
AKG Innovations LLC