Label: PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH- sodium fluoride paste, dentifrice

  • NDC Code(s): 70766-012-01, 70766-012-02, 70766-012-03, 70766-012-04, view more
    70766-012-05, 70766-012-06, 70766-012-07, 70766-012-08
  • Packager: Yangzhou SION Commodity Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 7, 2024

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  • Active ingredients

    SODIUM FLUORIDE 0.24% (0.10 w/v Fluoride ion)

    <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE 0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

    Purpose

    Anti-cavity toothpaste

  • Uses

    Aids in the prevention of cavities.

  • Warnings

    Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

    Do not use if the inner foil is torn, cut, or missing

    Keep out of reach of children.

  • Directions

    • Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician
    • Do not swallow
    • To minimize wallowing, use a pea sizes amount in children under 6 years
    • Supervise children's brushing until good habits are established
    • Children under 2 years of age: consult a dentist or physician
  • INACTIVE INGREDIENT

    Sorbitol, Water, Silica, PEG-400, Sodium lauryl sulfate, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium sacharine, Sodium benzoate, Trisodium phosphate, CI 42090

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70766-012
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRISODIUM PHOSPHIDE (UNII: A360RQX9W2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70766-012-01144 in 1 BOX01/04/2024
    124 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70766-012-025 in 1 CARTON01/04/2024
    224 in 1 BOX
    228 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:70766-012-06480 in 1 BOX01/04/2024
    328 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:70766-012-03144 in 1 BOX01/04/2024
    450 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:70766-012-0472 in 1 BOX01/04/2024
    5100 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:70766-012-05144 in 1 BOX01/04/2024
    6100 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:70766-012-0772 in 1 BOX01/04/2024
    7120 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:70766-012-08144 in 1 BOX01/04/2024
    8120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/04/2024
    Labeler - Yangzhou SION Commodity Co.,Ltd (546806042)
    Registrant - Yangzhou SION Commodity Co.,Ltd (546806042)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou SION Commodity Co.,Ltd546806042manufacture(70766-012)
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