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

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

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: Anticaries

Warnings:
Ask a doctor before use if you have:
Bleeding or redness lasting more than 2 weeks.
Pain, swelling, pus, loose teeth, or more spacing between teeth.
These may be signs of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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.

Uses:
Aids in the prevention of dental cavities.

Questions?
1-253-946-2344

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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ATOMY PROPOLIS TOOTHPAS TE 50G 
sodium monofluorophosphate, sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1380
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.08 g  in 50 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorwhite (TRANSLUCENT WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52257-1380-24 in 1 CARTON12/01/2019
1NDC:52257-1380-150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02112/01/2019
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong 2 factory963271750manufacture(52257-1380)

Revised: 1/2024
Document Id: bf9632ba-2fdb-4d32-b069-b2533e94f974
Set id: 98d839e3-a1aa-c83d-e053-2995a90a7e79
Version: 5
Effective Time: 20240130
 
ATOMY CO., LTD.