ATOMY PROPOLIS TOOTHPAS TE 50G- sodium monofluorophosphate, sodium fluoride paste, dentifrice

ATOMY PROPOLIS TOOTHPAS TE 50G by

Drug Labeling and Warnings

ATOMY PROPOLIS TOOTHPAS TE 50G by is a Otc medication manufactured, distributed, or labeled by ATOMY CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong 2 factory. 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

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.

Directions

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.

INGREDIENTS AND APPEARANCE

ATOMY PROPOLIS TOOTHPAS TE 50G 
sodium monofluorophosphate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1380
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.08 g  in 50 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 50 g

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

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: 52257-1380-2	4 in 1 CARTON	12/01/2019
1	NDC: 52257-1380-1	50 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	12/01/2019

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(52257-1380)