PLAK SMACKER ANTI CAVITY FLUORIDE- sodium fluoride paste
Yangzhou Hongshengding Chemical Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Plak Smacker GREAT WHITE SHARK ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	02/11/2016

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

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

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