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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 18, 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. 3.7 oz (106 g)

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

    Euthymol_Extraordinary_Pink_Whitening_106g_IC

    Euthymol_Extraordinary_Pink_Whitening_106g_OC

  • INGREDIENTS AND APPEARANCE
    EUTHYMOL EXTRAORDINARY PINK WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-561
    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:53208-561-061 in 1 CARTON09/18/2023
    1106 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/18/2023
    Labeler - LG H&H CO., LTD. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(53208-561)
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