ATOMY PROPOLIS TOOTHPAS TE 200g by ATOMY CO., LTD. / Kolmar Korea Co., Ltd.

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ATOMY PROPOLIS TOOTHPAS TE 200G- 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

Image of cartonImage of carton

ATOMY PROPOLIS TOOTHPAS TE 200G 
sodium monofluorophosphate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52257-1360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.32 g  in 200 g
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.20 g  in 200 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52257-1360-21 in 1 CARTON08/01/201611/01/2019
1NDC: 52257-1360-1200 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/01/201611/01/2019
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.688732723manufacture(52257-1360)

Revised: 12/2019
 
ATOMY CO., LTD.