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 DINOSAUR 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

1

PLAK SMACKER ANTI CAVITY FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-700
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71035-700-014 in 1 CARTON02/11/2016
1144 in 1 BOX
124 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:71035-700-026 in 1 CARTON02/11/2016
212 in 1 BOX
2120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/11/2016
Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-700)

Revised: 1/2018
Document Id: 62175f7d-6bc6-2fb8-e053-2991aa0adb4b
Set id: 403e7a1f-ca55-23be-e054-00144ff88e88
Version: 2
Effective Time: 20180106
 
Yangzhou Hongshengding Chemical Co.,Ltd.