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Plak Smacker Anti Cavity Fluoride

Medically reviewed on January 6, 2018

Dosage form: paste
Ingredients: SODIUM FLUORIDE 0.24g in 100g
Labeler: Yangzhou Hongshengding Chemical Co.,Ltd.
NDC Code: 71035-700

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.

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

PLAK SMACKER ANTI CAVITY FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-700
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
HYDRATED SILICA 
DISODIUM ETHYLENE DIMYRISTAMIDE PEG-15 DISULFATE 
SACCHARIN SODIUM 
SODIUM BENZOATE 
WATER 
DISODIUM CARBOXYMETHYLARSONATE 
SODIUM LAURYL SULFATE 
Packaging
#Item CodePackage Description
1NDC:71035-700-014 BOX in 1 CARTON
1144 TUBE in 1 BOX
124 g in 1 TUBE
2NDC:71035-700-026 BOX in 1 CARTON
212 TUBE in 1 BOX
2120 g in 1 TUBE
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/FEIOperations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-700)

 
Yangzhou Hongshengding Chemical Co.,Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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