PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH

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 22:38:23

Label at a glance#

ProductPROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

■Aids in the prevention of dental cavities

Dosage and administration

 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 o...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

■Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Stop use and ask a dentist

OTC - ASK DOCTOR SECTION

if oral irritation or tooth sensitivity occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  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

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

■Store at room temperature.

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH with Fluoride (62111-0212-4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

MouthWashBottleMouthWashBottle

MouthWashCartonMouthWashCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62111-0212-42019-11-27C16284748780-19855e2a2-3876-60a7-e053-dbdaa90a05bdPROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62111-0212-4PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH220 mL in 1 BOTTLEMOUTHWASH2201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62111-0212PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH (SODIUM FLUORIDE) MOUTHWASH [AKG INNOVATIONS LLC]1Legacy NDC, 1 package rows20140214_86d82d94-9439-4272-8ec2-8a014496d1bf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9V1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SALVADORA PERSICA ROOTINACTIVE INGREDIENT526M7ZU6161
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1
ZINC LACTATEINACTIVE INGREDIENT2GXR25858Y1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62111-021262111-0212-4

Ingredients#

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

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

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 · 287 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYDROGEN PEROXIDEHYDROGEN PEROXIDEBBX060AN9VSPONGE / TOPICAL0.2 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / ORAL600 mgExact identifier — unii candidate
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYCONCENTRATE / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / RECTAL406 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGEN PEROXIDEHYDROGEN PEROXIDEBBX060AN9VTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYSTEM / TOPICAL6300 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
31539b3c-ad6e-4c7f-b464-2c5ed6daa71186d82d94-9439-4272-8ec2-8a014496d1bf2014-02-14WarningsExact identifier
spl id: 31539b3c-ad6e-4c7f-b464-2c5ed6daa711
spl set id: 86d82d94-9439-4272-8ec2-8a014496d1bf

Reported adverse events (FAERS/openFDA)#

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