Dr.Whitiss 20%

Manufacturer
Nibec Co., Ltd
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:58

Label at a glance#

ProductDr.Whitiss 20%
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

carbamide peroxide


INACTIVE INGREDIENT SECTION

pyrrolidone (k=90), hydroxyethyl cellulose, glycerin, purified water, monobasic potassium phosphate, sodiu hydroxide, l-menthol, potassium nitrate, anhydrous ethanol

OTC - PURPOSE SECTION

whitening of discolored teeth


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION


1. Gingival and general oral heath should be confirmed before treatment.
2. Brush your teeth before treatment.
3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray.
4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.)
5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes.
6. If significant sensitivity occurs, stop treatment and consult dentist.


WARNINGS SECTION

1) do not use on patient with sensitive to carbamide peroxide
2) do not use on patient with oral infection
3) no to be used by pregnant or lactating women or children under 18 years old
4) to be used under the supervision of a dentist
5) do not swallow this medication


DOSAGE & ADMINISTRATION SECTION

for dental use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1653117carbamide peroxide 20 % Oral GelPSN2
1653117carbamide peroxide 0.2 MG/MG Oral GelSCD2
1653117carbamide peroxide 20 % Dental GelSY2
1653117carbamide peroxide 20 % Oral GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47649-1201-22024-07-30C16284748780-11030e365-227c-111a-e063-dadaa90a10e2Drug Facts
47649-1201-22024-01-30C16284748780-11030e365-227c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47649-1201-1Dr.Whitiss 20%1 g in 1 SYRINGEGEL, DENTIFRICE12
47649-1201-2Dr.Whitiss 20%4 in 1 PACKAGEGEL, DENTIFRICE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47649-1201DR.WHITISS 20% (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]2Legacy NDC, 2 package rows20181227_bec3a349-b42c-4cd7-a1c1-1379ab1c7e77.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU811
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0Z1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5Z1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47649-120147649-1201-1, 47649-1201-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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 2 · 94 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION/ DROPS / AURICULAR (OTIC)2 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSYSTEM / TRANSDERMAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / TRANSDERMAL100 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE, DELAYED RELEASE / ORAL137 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSUSPENSION/ DROPS / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, EXTENDED RELEASE / ORAL498 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE / ORAL270 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION/ DROPS / OPHTHALMIC1.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSUSPENSION / ORAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET / ORAL966 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSYSTEM / TOPICAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, COATED / ORAL9.77 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 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
f3ace331-4bc8-0b32-e053-2995a90a8823bec3a349-b42c-4cd7-a1c1-1379ab1c7e772023-02-01WarningsExact identifier
spl set id: bec3a349-b42c-4cd7-a1c1-1379ab1c7e77

Reported adverse events (FAERS/openFDA)#

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