PLAK SMACKER- sodium fluoride paste, dentifrice 
Dental Technologies, Inc

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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Drug Facts

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

Do not use if inner foil is torn, cut or missing.

Keep out of 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.

Directions

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Questions or comments?

1-800-558-6684

"The ADA Council on Scientific Affairs'

Acceptance of Plak Smacker® Great White

Shark Fluoride Gel Toothpaste is based on

its finding that the product is effective in

helping to prevent and reduce tooth decay,

when used as directed."

Distributed by: PLAK SMACKER® 00181

Corona, CA 92879                         REV1

(800) 558-6684 www.plaksmacker.com

Principal Display Panel

PLAK SMACKER®

GREAT WHITE

SHARK

NO

SUGAR

ADDED

ADA

ACCEPTED

American Dental Association

COOL BERRY FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2 OZ (120G)

image description

PLAK SMACKER 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55346-0718
Route of AdministrationDENTAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 300 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 1450 
SACCHARIN SODIUM 
METHYLPARABEN 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Cool Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-0718-2120 g in 1 TUBE
2NDC:55346-0718-124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/31/2007
Labeler - Dental Technologies, Inc (148312838)

Revised: 3/2013
Document Id: d7e8c3f7-eb2a-448c-af0e-a8c275c3fbf4
Set id: 0de9d469-1a66-4b40-b7c9-dcfa47e8e244
Version: 1
Effective Time: 20130322
 
Dental Technologies, Inc