Label: PLAK SMACKER- sodium fluoride paste, dentifrice
- NDC Code(s): 55346-0718-1, 55346-0718-2
- Packager: Dental Technologies, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 1, 2015
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- Active Ingredient
Sodium Fluoride 0.24%
(0.14% w/v fluoride ion)Close
Helps aid in the prevention of dental cavities.Close
Do not use if inner foil is torn, cut or missing.Close
- Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.Close
- 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 a doctor.
- Do not swallow
- To minimum swallowing use a pea sized amount in children under 6
- Instruct children under 6 years of age in good brushing and rinsing habits
- Supervise children as necessary until capable of using without supervision
- Inactive Ingredients
Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1Close
- Questions or comments?
- Principal Display Panel
COOL BERRY FLAVOR
ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
NET WT. 4.2 OZ (120G)
- INGREDIENTS AND APPEARANCE
sodium fluoride paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55346-0718 Route of Administration ORAL, DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) SACCHARIN SODIUM (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color Score Shape Size Flavor BERRY (Cool Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55346-0718-2 120 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:55346-0718-1 24 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 final part355 12/31/2007 Labeler - Dental Technologies, Inc (148312838)