Label: ETT HOJAKDO- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 83672-001-01, 83672-001-02
  • Packager: LIFE STEALER Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 16, 2024

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  • active ingredient

    Sodium Monofluorophosphate 0.758%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • Purpose

    Anticavity

  • Uses

    Helps protect against cavities

  • Warnings

    Ask a dentist before use if you have 

    - bleeding or redness lasting more than 2 weeks

    - pain, waelling, pus, loose teeth, or more spacing between teeth

    These may be signs of periodontitis, a serious form of gum disease.

  • Directions

    Adults and children 6 years of age and older

    Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

    ETT HOJAKDO toothpaste is high concentration formula toothpaste. Please use sparingly. A lentil-sized amount is enough.

    Children under 12 years old

    Instruct in good brushing and rinsing habits (to minimize swallowing)

    Children under 6 years old

    Do not use unless directed by a dentist or a physician

  • Inactive Ingredients

    Silica, Tetrasodium Pyrophosphate, Alcloxa, Sorbitol, Glycerin, Cellulose Gum, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Xylitol, Glucosyl stevia, Sodium Saccharin, Centella Asiatica Leaf Extract, Chamomilla Recutita (Matricaria) Extract, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Menthol, Mentha Pulegium Oil, Anethole, Flavor, Water

  • PRINCIPAL DISPLAY PANEL

    Life stealers

  • INGREDIENTS AND APPEARANCE
    ETT HOJAKDO 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83672-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.758 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    ALCLOXA (UNII: 18B8O9DQA2)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PENNYROYAL OIL (UNII: AK85U7Y3MV)  
    ANETHOLE (UNII: Q3JEK5DO4K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83672-001-021 in 1 CARTON09/14/2023
    1NDC:83672-001-01100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02109/14/2023
    Labeler - LIFE STEALER Co., Ltd. (695909253)
    Registrant - LIFE STEALER Co., Ltd. (695909253)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(83672-001)
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