Label: PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH- sodium fluoride paste, dentifrice
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NDC Code(s):
70766-012-01,
70766-012-02,
70766-012-03,
70766-012-04, view more70766-012-05, 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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/><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;lt;/text>&amp;lt;/text>&lt;/text></text></text>
- Uses
- Warnings
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70766-012 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70766-012-01 144 in 1 BOX 01/04/2024 1 24 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:70766-012-02 5 in 1 CARTON 01/04/2024 2 24 in 1 BOX 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:70766-012-06 480 in 1 BOX 01/04/2024 3 28 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:70766-012-03 144 in 1 BOX 01/04/2024 4 50 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:70766-012-04 72 in 1 BOX 01/04/2024 5 100 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:70766-012-05 144 in 1 BOX 01/04/2024 6 100 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:70766-012-07 72 in 1 BOX 01/04/2024 7 120 g in 1 TUBE; Type 0: Not a Combination Product 8 NDC:70766-012-08 144 in 1 BOX 01/04/2024 8 120 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M005 01/04/2024 Labeler - Yangzhou SION Commodity Co.,Ltd (546806042) Registrant - Yangzhou SION Commodity Co.,Ltd (546806042) Establishment Name Address ID/FEI Business Operations Yangzhou SION Commodity Co.,Ltd 546806042 manufacture(70766-012)