PLAK SMACKER- stannous fluoride gel 
Young Dental Manufacturing Co 1, LLC.

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.

This product 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.

Do not use

if inner foil is torn, cut or missing.

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.

Inactive Ingredients:

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

Questions or comments?

1-800-558-6684 or 951-898-7600

"The ADA Council on Scientific Affairs'

Acceptance of Plak Smacker® Home Care

Fluoride Gel 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®

755 Trademark Circle, Corona, CA 92879

www.plaksmacker.com

Principal Display Panel

HOME CARE

FLUORIDE GEL

0.4% STANNOUS FLUORIDE

Savory Strawberry

11427

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

ADA ACCEPTED

AMERICAN DENTAL ASSOCIATION

PLAK SMACKER

NET WEIGHT - 4.3 oz. (121.9g)

image of carton

PLAK SMACKER 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0273-0414
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
FlavorSTRAWBERRY (Savory Strawberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-0414-20121.9 g in 1 TUBE; Type 0: Not a Combination Product12/31/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/31/200701/23/2018
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)

Revised: 1/2018
 
Young Dental Manufacturing Co 1, LLC.