PROFESSIONAL WHITENING SYSTEM WHITENING

Manufacturer: AKG Innovations LLC | Wasatch Product Development LLC
Effective date: 2014-02-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:38:24

Label at a glance#

ProductPROFESSIONAL WHITENING SYSTEM WHITENING

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact1-855-333-2544

Websitewww.arthurglosmandentalbeauty.com

www.arthurglosmandentalbeauty.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PROFESSIONALWHITENING SYSTEM WHITENINGTOOTHPASTE with Fluoride

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.23%...

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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:

OTC - QUESTIONS SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1489127	sodium fluoride 0.23 % Toothpaste	PSN	1
1489127	sodium fluoride 0.0023 MG/MG Toothpaste	SCD	1
1489127	sodium fluoride 0.23 % Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62111-0213-2	2019-11-27	C162847	48780-1	9855e2a2-3531-60a7-e053-dbdaa90a05bd	PROFESSIONAL WHITENING SYSTEM WHITENING TOOTHPASTE with Fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62111-0213-2	PROFESSIONAL WHITENING SYSTEM WHITENING	113.6 g in 1 TUBE	PASTE	113.6		1
62111-0213-2	PROFESSIONAL WHITENING SYSTEM WHITENING	1 in 1 PACKAGE	PASTE	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62111-0213	PROFESSIONAL WHITENING SYSTEM WHITENING (SODIUM FLUORIDE) PASTE [AKG INNOVATIONS LLC]	1	Legacy NDC, 2 package rows	20140214_b208dc26-c3ec-4325-bfb9-af1984236a28.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	1
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	1
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
SALVADORA PERSICA ROOT	INACTIVE INGREDIENT	526M7ZU616	1
SODIUM LAUROYL SARCOSINATE	INACTIVE INGREDIENT	632GS99618	1
SODIUM SARCOSINATE	INACTIVE INGREDIENT	6EHN3PQL8Z	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

PROFESSIONAL WHITENING SYSTEM WHITENING
SODIUM FLUORIDE
FLUORIDE ION
WATER
SORBITOL
HYDRATED SILICA
GLYCERIN
XYLITOL
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAUROYL SARCOSINATE
SODIUM SARCOSINATE
CARRAGEENAN
TITANIUM DIOXIDE
HYDROGEN PEROXIDE
MENTHOL
SALVADORA PERSICA ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62111-0213	62111-0213-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM LAUROYL SARCOSINATE	632GS99618	IACT
SODIUM SARCOSINATE	6EHN3PQL8Z	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
HYDROGEN PEROXIDE	BBX060AN9V	IACT
MENTHOL	L7T10EIP3A	IACT
SALVADORA PERSICA ROOT	526M7ZU616	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 254 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	SUSPENSION / ORAL	6 mg/5ml		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CAPSULE / ORAL	0.87 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	INSERT, EXTENDED RELEASE / OPHTHALMIC	0.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, EXTENDED RELEASE / ORAL		933 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	AEROSOL, FOAM / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOAP / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	CAPSULE / ORAL		3 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	POWDER, FOR SUSPENSION / ORAL	15 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET / BUCCAL	4 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	BBX060AN9V	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
CARRAGEENAN	CARRAGEENAN	5C69YCD2YJ	GRANULE, FOR SUSPENSION / ORAL		161 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CREAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
7a426e80-7e89-4f1e-8c92-0c6c09abd0ac			b208dc26-c3ec-4325-bfb9-af1984236a28	2014-02-14	Warnings	Exact identifier spl id: 7a426e80-7e89-4f1e-8c92-0c6c09abd0ac spl set id: b208dc26-c3ec-4325-bfb9-af1984236a28

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.