PLAK SMACKER GREAT WHITE SHARK- sodium fluoride paste

Plak Smacker GREAT WHITE SHARK by

Drug Labeling and Warnings

Plak Smacker GREAT WHITE SHARK 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. 

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 peasized 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 1500, Sodium Lauryl Sulfate, Flavor , Sodium Carboxy Methyl Cellulose , Sodium Saccharin, Sodium Benzoate,  Blue1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PLAK SMACKER GREAT WHITE SHARK 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72326-8003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72326-8003-1	120 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2018
2	NDC: 72326-8003-2	24 g in 1 TUBE; Type 0: Not a Combination Product	06/22/2018
3	NDC: 72326-8003-3	24 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2018

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)