ETT HOJAKDO- sodium monofluorophosphate paste, dentifrice

ETT HOJAKDO by

Drug Labeling and Warnings

ETT HOJAKDO by is a Otc medication manufactured, distributed, or labeled by LIFE STEALER Co., Ltd., K.Boeun Pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredient

Sodium Monofluorophosphate 0.758%

KEEP OUT OF REACH OF CHILDREN

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

Purpose

Anticavity

Uses

Helps protect against cavities

Warnings

Ask a dentist before use if you have 

- bleeding or redness lasting more than 2 weeks

- pain, waelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

Adults and children 6 years of age and older

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

ETT HOJAKDO toothpaste is high concentration formula toothpaste. Please use sparingly. A lentil-sized amount is enough.

Children under 12 years old

Instruct in good brushing and rinsing habits (to minimize swallowing)

Children under 6 years old

Do not use unless directed by a dentist or a physician

Inactive Ingredients

Silica, Tetrasodium Pyrophosphate, Alcloxa, Sorbitol, Glycerin, Cellulose Gum, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Xylitol, Glucosyl stevia, Sodium Saccharin, Centella Asiatica Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Menthol, Mentha Pulegium Oil, Anethole, Flavor, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETT HOJAKDO 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83672-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.758 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
ALCLOXA (UNII: 18B8O9DQA2)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
GLUCOSYL STEVIOL (UNII: TKD5UC898Q)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PENNYROYAL OIL (UNII: AK85U7Y3MV)
ANETHOLE (UNII: Q3JEK5DO4K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83672-001-02	1 in 1 CARTON	09/14/2023
1	NDC: 83672-001-01	100 g in 1 TUBE; 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	09/14/2023

Labeler - LIFE STEALER Co., Ltd. (695909253)

Registrant - LIFE STEALER Co., Ltd. (695909253)

Establishment
Name	Address	ID/FEI	Business Operations
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(83672-001)