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 Type HUMAN OTC DRUG Item Code (Source) NDC:55346-0718
Route of Administration DENTAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY (Cool Berry) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-0718-2 120 g in 1 TUBE
2 NDC:55346-0718-1 24 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/31/2007
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