ATOMY PROPOLIS TOOTHPAS TE 50g by ATOMY CO., LTD. / Kolmar Korea Co., Ltd.

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52257-1350
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
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52257-1350-2	4 in 1 CARTON	08/01/2016	11/01/2019
1	NDC: 52257-1350-1	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	08/01/2016	11/01/2019

Labeler - ATOMY CO., LTD. (631154601)

Registrant - ATOMY CO., LTD. (631154601)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(52257-1350)

Revised: 12/2019

Document Id: 61555989-30bd-423a-8c2a-500b78b1859e

34390-5

Set id: d7affe9b-1d90-47c1-bc22-4a5e64260d1d

Version: 2

Effective Time: 20191223

 

ATOMY CO., LTD.