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Plak Smacker by Dental Technologies, Inc.

Medically reviewed on October 2, 2017

Dosage form: gel
Ingredients: STANNOUS FLUORIDE 0.969mg in 1g
Labeler: Dental Technologies, Inc.
NDC Code: 55346-0412

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.

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
  • Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

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)

PLAK SMACKER 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55346-0412
Route of AdministrationDENTAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION0.969 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
ANHYDROUS CITRIC ACID 
GLYCERIN 
TROLAMINE 
CARBOMER 934 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (Bubblegum Burst) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55346-0412-2121.9 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)

 
Dental Technologies, Inc.

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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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