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 Yangzhou Hongshengding Chemical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

anticavity toothpaste

Uses

help aids 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 swalowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Adults and children 2years 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 oa age in good brushing and rinsing habits.

supervise children as necessary until capable of useing without supervision

INACTIVE INGREDIENT

Sorbitol,Water ,Hydreated silica,PEG1500,Sodium Lauryl Sulfate,Flavor ,Sodium Carboxy Methyl Cellulose ,Sodium Saccharin,Sodium Benzoate,Blue1

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: 71035-600
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 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: 71035-600-01	4 in 1 CARTON	02/11/2016
1		144 in 1 BOX
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71035-600-02	6 in 1 CARTON	02/11/2016
2		12 in 1 BOX
2		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 not final	part356	02/11/2016

Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-600)