PLAK SMACKER ANTI CAVITY FLUORIDE- sodium fluoride paste

Plak Smacker Anti Cavity Fluoride by

Drug Labeling and Warnings

Plak Smacker Anti Cavity Fluoride by is a Otc medication manufactured, distributed, or labeled by YOUNG PS ACQUISITION, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 0.24%(0.14% w/v Fluoride ion)

Purpose

Anticavity toothpaste

Uses

Helps aid in the prevention of dental cavities.

Warnings

Keep out of the 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.

Do not use if 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, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
• Do not swallow
• To minimize 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, PEG1500, Sodium Lauryl Sulfate, Flavor , Sodium Carboxy Methyl Cellulose , Sodium Saccharin,Sodium Benzoate, Blue1, Red 33 

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLAK SMACKER ANTI CAVITY FLUORIDE 
sodium fluoride paste

Product 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	14 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISODIUM ETHYLENE DIMYRISTAMIDE PEG-15 DISULFATE (UNII: X2CDV8U82V)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)

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	07/23/2018
2	NDC: 72326-8002-2	120 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2018
3	NDC: 72326-8002-3	24 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/27/2018

Labeler - YOUNG PS ACQUISITION, LLC (119620784)

Registrant - YOUNG PS ACQUISITION, LLC (119620784)