PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH- sodium fluoride mouthwash

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH by

Drug Labeling and Warnings

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH 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

Drug Facts

Active ingredient

Sodium fluoride 0.02%

Purpose

Anticavity

Uses

■Aids in the prevention of dental cavities

WARNINGS

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

•  Adults and children 12 years of

  age or older:

  use twice daily after brushing your

  teeth with a toothpaste

  vigorously swish 10 ml (2 teaspoonfuls)

  of rinse between your teeth for 1 minute

  and then spit out

  do not swallow the rinse

  do not eat or drink for 30 minutes

  after rinsing

  supervise children as necessary until

  capable of using without supervision

  Children under 12 years of age consult

  a dentist or doctor

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

INGREDIENTS AND APPEARANCE

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62111-0212
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62111-0212-4	220 mL in 1 BOTTLE

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(62111-0212)