PROFESSIONAL WHITENING SYSTEM WHITENING- sodium fluoride paste

PROFESSIONAL WHITENING SYSTEM WHITENING by

Drug Labeling and Warnings

PROFESSIONAL WHITENING SYSTEM WHITENING by is a Otc medication manufactured, distributed, or labeled by AKG Innovations LLC, Wasatch Product Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PROFESSIONALWHITENING SYSTEM WHITENINGTOOTHPASTE with Fluoride

Active Ingredient

SODIUM FLUORIDE 0.23%...

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

WARNINGS

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

INGREDIENTS AND APPEARANCE

PROFESSIONAL WHITENING SYSTEM WHITENING 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62111-0213
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62111-0213-2	1 in 1 PACKAGE
1		113.6 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/14/2014

Labeler - AKG Innovations LLC (056576137)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Product Development LLC		962452533	manufacture(62111-0213)