Professional Whitening System Whitening Mouth Wash

Professional Whitening System Whitening Mouth Wash
SPL v1
SPL
SPL Set ID 86d82d94-9439-4272-8ec2-8a014496d1bf
Route
ORAL
Published
Effective Date 2014-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (.2 mg)
Inactive Ingredients
Water Xylitol Glycerin Sorbitol Castor Oil Menthol Hydrogen Peroxide Potassium Sorbate Sodium Benzoate Saccharin Sodium Ascorbic Acid Salvadora Persica Root Zinc Lactate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-14

Description

Drug Facts

Purpose

Anticavity


Medication Information

Warnings and Precautions

Warnings

Purpose

Anticavity

Description

Drug Facts

Uses

■Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

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

Questions?

Call Customer Service-toll-free

1.855.333.2544 or visit

www.arthurglosmandentalbeauty.com

Active Ingredient

Sodium fluoride 0.02%

Other Information

■Store at room temperature.

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.

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.

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


Structured Label Content

Uses

■Aids in the prevention of dental cavities

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Purpose

Anticavity

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

Questions?

Call Customer Service-toll-free

1.855.333.2544 or visit

www.arthurglosmandentalbeauty.com

Active Ingredient (Active ingredient)

Sodium fluoride 0.02%

Other Information (Other information)

■Store at room temperature.

Inactive Ingredients (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.

Stop Use and Ask A Dentist (Stop use and ask a 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.

Professional Whitening System Whitening Mouth Wash With Fluoride (62111 0212 4) (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


Advanced Ingredient Data


Raw Label Data

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