DoctorTibletKereale

Manufacturer: TRAUM TRADERS | Sungwon Pharmaceutical Co., Ltd
Effective date: 2018-01-29
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:54:17

Label at a glance#

ProductDoctorTibletKereale

Active ingredientSodium Fluoride

Label structure8 sections

Indications and uses

Uses: Help better oral hygiene and freshness breath.

Dosage and administration

Directions: Take one of Kereale mouth rinse tablet chewing until it melting completely in your mouth and mix with some water then spit it out.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Sodium Fluoride 0.22%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: D-Sorbitol, Sodium Lauryl Sulfate, Silicon Dioxide, Xylitol, microcrystalline cellulose, Mint Flavor, Magnesium Sterate, L-Menthol, Hydroxypropylellulose, Tetrasodium Pyrophosphate, sodium hydrogen carbonate, aspartame, Arabic Gum, Pyridoxine HCI, Ascorbic Acid

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticaries

WARNINGS

WARNINGS SECTION

Warnings: Keep out of the reach of children under 6 years of age. Do not use children because they may swallow. If large quantities have been swallowed, consult a physician immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Uses

INDICATIONS & USAGE SECTION

Uses: Help better oral hygiene and freshness breath.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Take one of Kereale mouth rinse tablet chewing until it melting completely in your mouth and mix with some water then spit it out.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72047-010-02	2020-01-31	C162847	48780-1	9d75b9cf-e5b5-f424-e053-dadaa90a57ce	9927bc9e-84e5-4b08-b729-ec2769b4cbd3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72047-010-01	DoctorTibletKereale	0.7 g in 1 BLISTER PACK	PASTE, DENTIFRICE	0.7		1
72047-010-02	DoctorTibletKereale	60 in 1 CARTON	PASTE, DENTIFRICE	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72047-010	DOCTORTIBLETKEREALE (SODIUM FLUORIDE) PASTE, DENTIFRICE [TRAUM TRADERS]	1	Legacy NDC, 2 package rows	20180129_9927bc9e-84e5-4b08-b729-ec2769b4cbd3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

DoctorTibletKereale
Sodium Fluoride
FLUORIDE ION
SODIUM LAURYL SULFATE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
72047-010	72047-010-01, 72047-010-02

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
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
SODIUM LAURYL SULFATE	368GB5141J	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT

Source Document#

Source XML

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
9445c4dc-3e6d-4250-aac7-06a826046e71			9927bc9e-84e5-4b08-b729-ec2769b4cbd3	2018-01-29	Warnings	Exact identifier spl id: 9445c4dc-3e6d-4250-aac7-06a826046e71 spl set id: 9927bc9e-84e5-4b08-b729-ec2769b4cbd3

Reported adverse events (FAERS/openFDA)#

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