Label: PLAK SMACKER ANTI CAVITY FLUORIDE- sodium fluoride paste
- NDC Code(s): 72326-8002-1, 72326-8002-2, 72326-8002-3
- Packager: YOUNG PS ACQUISITION, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 16, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- DO NOT USE
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Directions
- Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
- Do not swallow
- To minimize swallowing use a pea sized 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 Ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PLAK SMACKER ANTI CAVITY FLUORIDE
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72326-8002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) HYDRATED SILICA (UNII: Y6O7T4G8P9) SACCHARIN SODIUM (UNII: SB8ZUX40TY) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72326-8002-1 24 g in 1 TUBE; Type 0: Not a Combination Product 07/12/2023 2 NDC:72326-8002-2 120 g in 1 TUBE; Type 0: Not a Combination Product 07/12/2023 3 NDC:72326-8002-3 24 g in 1 TUBE; Type 0: Not a Combination Product 07/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 05/27/2018 Labeler - YOUNG PS ACQUISITION, LLC (119620784) Registrant - YOUNG PS ACQUISITION, LLC (119620784)