Label: EUTHYMOL EXTRAORDINARY PINK WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    Sodium Fluoride 0.243% (0.16% w/v fluoride ion)

  • Purpose

    Anticavity toopaste

  • Use

    helps protect against cavities

  • Warnings

    Warnings

    Keep out of reach of children.

    Keep out of reach of children under 6 years of age. Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

  • Directions

    • adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
    • ​Do not swallow.
    • ​to minimize swallowing use a pea-sized amount in children under 6.
    • ​Supervise children's brushing until good habits are established.
    • ​ Children under 2 years: ask a dentist.
  • Inactive Ingredients

    GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, FLAVOR, TRISODIUM PHOSPHATE, SODIUM LAURYL SULFATE, CARRAGEENAN, COCAMIDOPROPYL BETAINE, SODIUM SACCHARIN, SUCRALOSE, XANTHAN GUM, TITANIUM DIOXIDE, MICA, CHARCOAL POWDER, CITRUS LIMON(LEMON) FRUIT EXTRACT, SODIUM CHLORIDE

  • Questions?

    1-866-993-4709

  • Principal Display Panel - 106 g Tube Carton

    EXTRAORDINARY

    PINK WHITENING

    EUTHYMOL


    Whiter Teeth in Just 1 Week

    Formulated without BPA, phthalates, preservatives, peroxide, or animal ingredients.

    Fluoride Toothpaste

    Wintergreen Mint

    net wt. 0.7 oz (20 g)

    DIST. LG H&H CO., LTD.
    58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA
    www.lghnh.com
    MADE IN KOREA

    Euthymol_extraordinary_pink_whitening_20g

  • INGREDIENTS AND APPEARANCE
    EUTHYMOL EXTRAORDINARY PINK WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-562
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MICA (UNII: V8A1AW0880)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWINTERGREEN (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-562-201 in 1 CARTON10/23/2023
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02110/23/2023
    Labeler - LG H&H CO., LTD. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(53208-562)
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