ATOMY PROPOLIS TOOTHPAS TE 200G- sodium monofluorophosphate, sodium fluoride paste, dentifrice

ATOMY PROPOLIS TOOTHPAS TE 200G by

Drug Labeling and Warnings

ATOMY PROPOLIS TOOTHPAS TE 200G by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co., Ltd_Sandan 4th Branch, KOLMAR KOREA CO., LTD. Gwanjeong 2 branch. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%

INACTIVE INGREDIENT

Inactive Ingredients: SORBITOL, HYDRATED SILICA, WATER, SILICA, SODIUM LAURYL SULFATE, TETRASODIUM PYROPHOSPHATE, PEG-32, CELLULOSE GUM, CITRUS FLAVOR, CITRUS AURANTIUM DULCIS(ORANGE) PEEL OIL, MINT FLAVOR, SODIUM SACCHARIN, XYLITOL, CAMELLIA SINENSIS EXTRACT, MENTHOL, PROPOLIS EXTRACT

PURPOSE

Purpose: Anticaries

WARNINGS

Warnings: If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

N/A

INDICATIONS & USAGE

Directions: 1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ATOMY PROPOLIS TOOTHPAS TE 200G 
sodium monofluorophosphate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1370
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2 g  in 200 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.32 g  in 200 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	white (Translucent white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1370-2	1 in 1 CARTON	12/01/2019
1	NDC: 52257-1370-1	200 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	11/25/2019

Labeler - ATOMY CO., LTD. (631154601)

Registrant - Kolmar Korea Co., Ltd_Sandan 4th Branch (695640162)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd._Sandan 4th Branch		695640162	manufacture(52257-1370)