DOCTORTIBLETKEREALE- sodium fluoride paste, dentifrice

DoctorTibletKereale by

Drug Labeling and Warnings

DoctorTibletKereale by is a Otc medication manufactured, distributed, or labeled by TRAUM TRADERS, Sungwon Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Sodium Fluoride 0.22%

INACTIVE INGREDIENT

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

Purpose: Anticaries

WARNINGS

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

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

Uses

Uses: Help better oral hygiene and freshness breath.

Directions

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

INGREDIENTS AND APPEARANCE

DOCTORTIBLETKEREALE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72047-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.001 g  in 0.7 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72047-010-02	60 in 1 CARTON	01/02/2018
1	NDC: 72047-010-01	0.7 g in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/02/2018

Labeler - TRAUM TRADERS (694894613)

Registrant - TRAUM TRADERS (694894613)

Establishment
Name	Address	ID/FEI	Business Operations
Sungwon Pharmaceutical Co., Ltd		689787898	manufacture(72047-010)