Label: HIMALAYA PINK SALT PURPLE COLOR CORRECTOR PLUS INTENSIVE WHITENING TOOTHPASTE- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 31, 2024

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  • Drug Facts

  • Active ingredient

    SODIUM FLUORIDE 0.243%
    (0.15% w/v fluoride ion)

  • Purpose

    Anticavity
    toopaste

  • Use

    helps protect against cavities

  • Warnings

    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, ZINC STEARATE, COCAMIDOPROPYL BETAINE, FLAVOR, SODIUM LAURYL SULFATE, CARRAGEENAN, POTASSIUM PHOSPHATE (tribasic), POTASSIUM PHOSPHATE (monobasic), POLOXAMER 407, SODIUM SACCHARIN, ALGIN, SODIUM CHLORIDE, TOCOPHERYL ACETATE, XANTHAN GUM, CI 42090, SUCRALOSE, TITANATED MICA, CI 17200

  • Questions?

    1-866-993-4709

  • SPL UNCLASSIFIED SECTION

    DISTR. LG H&H Co., Ltd.
    58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA

    MADE IN KOREA

  • SPL UNCLASSIFIED SECTION

    • 2.9X tone-up effect in just one use by reducing yellowness**
    • Clinically proven to white teeth 9.6X more than regular toothpaste*
    • Formulated without parabens, gluten, phthalates, triclosan
    • U.S. patented formula***

    * Compared to regular toothpaste without SHMP.
    ** 38% higher prevention compared to regular toothpaste without SHMP.
    *** Patent : US 11,701, 313 B2

  • Principal Display Panel:

    HIMALAYA
    PINK SALT

    Purple Color Corrector
    + Intensive Whitening

    fluoride anticavity
    toothpaste_ vanilla mint

    2.9X
    TONE-UP*

    9.6X WHITENING*
    24 HR STAIN RESISTANCE**
    ENAMEL STRENGTHENING


    NET WT. 3.5 OZ (100 g)

    himalaya_pink_salt_purple_color_corrector-intensive_whitening_oc

    himalaya_pink_salt_purple_color_corrector-intensive_whitening_tube

  • INGREDIENTS AND APPEARANCE
    HIMALAYA PINK SALT PURPLE COLOR CORRECTOR PLUS INTENSIVE WHITENING TOOTHPASTE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-592
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorMINT (Vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-592-101 in 1 CARTON05/31/2024
    1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/31/2024
    Labeler - LG H&H Co.,Ltd. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(53208-592)
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