PLAK SMACKER- stannous fluoride gel 
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

Stannous Fluoride 0.4%

Purpose

Anticavity

Uses

Helps aid in the prevention of dental cavities.

Warnings:

This is an anticavity fluoride preventive treatment gel, not a toothpaste.

Read directions carefully before using.

When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients:

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine.

Questions or comments?

1-800-558-6684

Principal Display Panel

Home Care

Fluoride Gel

0.4% Stannous Fluoride

Bubblegum Burst

11422

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK SMACKER

Net Weight 4.3 oz. (121.9g)

image of tube

PLAK SMACKER 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-0412
Route of AdministrationDENTAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 934 (UNII: Z135WT9208)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (Bubblegum Burst) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-0412-2121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/31/2007
Labeler - Dental Technologies, Inc. (148312838)

Revised: 10/2015
Document Id: 210c7778-9a64-4de2-e054-00144ff88e88
Set id: 6d1aae4f-37aa-435c-ada9-89678476dd8f
Version: 5
Effective Time: 20151001
 
Dental Technologies, Inc.