Plak Smacker description, usages, side effects, indications, overdosage, supplying and lots more!

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Plak Smacker

Dental Technologies, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Stannous Fluoride 0.4%

Purpose

Anticavity

Plak Smacker Uses

Helps aid in the prevention of dental cavities.

Warnings:

This is an anticavity fluoride preventative 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.

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

Cream Mint

11421

AIDS IN THE

PREVENTION

OF DENTAL CAVITIES

ADA ACCEPTED

AMERICAN DENTAL ASSOCIATION

PLAK SMACKER

Net Weight 4.3 oz. (121.9g)

Plak Smacker

Plak Smacker

Stannous Fluoride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55346-0411
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
stannous fluoride Fluoride Ion 0.969 mg

Inactive Ingredients

Ingredient Name Strength
ASCORBIC ACID
carbomer 934P
ANHYDROUS CITRIC ACID
GLYCERIN
TROLAMINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-0411-2 121.9 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2007-12-31


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