Tooth Whole White

Manufacturer
Hankuk Bowonbio Co., Ltd
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:46

Label at a glance#

ProductTooth Whole White
Active ingredientHYDROGEN PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

active ingredient:  xylitol


INACTIVE INGREDIENT SECTION

cetylpyridinium chloride, lactose monohydrate, corn starch, d-sorbitol, ubidecarenone, glycyrrhizae extract, tea chatechin, hydroxyapatite, propolis extract, menthol powder, spirulina color


OTC - PURPOSE SECTION

whiten and strong teeth
removal of bad breath
prevention of gingivitis and periodontitis
prevention of periodontal diseases and gum diseases
removal of dental plaque



OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

apply Proper Amount of the toothpaste on the tooth.

WARNINGS SECTION

■ For tooth only.
■ Avoid contact with eyes.
■ Do not swallow. If swallowed, get medical help.



DOSAGE & ADMINISTRATION SECTION

brush your teeth by putting appropriate amount of powder


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package insert
package insert

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60319-5001-12025-01-30C16284748780-12cef2736-75fa-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60319-5001-1Tooth Whole White80 g in 1 BOTTLE, PLASTICPASTE, DENTIFRICE802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60319-5001TOOTH WHOLE WHITE (HYDROGEN PEROXIDE) PASTE, DENTIFRICE [HANKUK BOWONBIO CO., LTD]2Legacy NDC, 1 package rows20191206_8362c780-80d6-44dd-ba09-71a7feba12c9.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60319-500160319-5001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
XYLITOLVCQ006KQ1EIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB

Source Document#

Source XML · Source PDF

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
990201fb-aeac-cf20-e053-2995a90a1ace8362c780-80d6-44dd-ba09-71a7feba12c92019-12-05WarningsExact identifier
spl id: 990201fb-aeac-cf20-e053-2995a90a1ace
spl set id: 8362c780-80d6-44dd-ba09-71a7feba12c9

Reported adverse events (FAERS/openFDA)#

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