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 to 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

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FLUORIDE GEL

0.4% STANNOUS FLUORIDE

Groovy Grape

11426

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

PLAK SMACKER

Net Weight 4.3 oz. (121.9g)

grape tube

PLAK SMACKER 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-0418
Route of AdministrationORAL, DENTAL
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)  
CARBOMER 934 (UNII: Z135WT9208)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Groovy Grape) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-0418-2121.9 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: 210c6251-660e-5b6a-e054-00144ff88e88
Set id: 3b21d029-271b-43f4-9406-429507621bf7
Version: 4
Effective Time: 20151001
 
Dental Technologies, Inc.