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

  • NDC Code(s): 52257-1370-1, 52257-1370-2
  • Packager: ATOMY CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2024

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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:

    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

    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.

  • DOSAGE & ADMINISTRATION

    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.

  • INDICATIONS & USAGE

    Uses:

    Aids in the prevention of dental cavities.

  • QUESTIONS

    Questions?
    1-253-946-2344

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cartonImage of carton

  • INGREDIENTS AND APPEARANCE
    ATOMY PROPOLIS TOOTHPAS TE 200G 
    sodium monofluorophosphate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1370
    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 ION0.2 g  in 200 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorwhite (Translucent white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52257-1370-21 in 1 CARTON12/01/2019
    1NDC:52257-1370-1200 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/25/2019
    Labeler - ATOMY CO., LTD. (631154601)
    Registrant - ATOMY CO., LTD. (631154601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong 2 factory963271750manufacture(52257-1370)
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