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

Sodium Fluoride 0.24%

(0.14% w/v fluoride ion)

Purpose

Anticavity toothpaste

Plak Smacker Uses

Helps aid in the prevention of dental cavities.

Warnings

Do not use if inner foil is torn, cut or missing.

Keep out of reach of children under 6 years of age.

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

Directions

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Do not swallow
  • To minimum swallowing use a pea sized amount in children under 6
  • Instruct children under 6 years of age in good brushing and rinsing habits
  • Supervise children as necessary until capable of using without supervision

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propylparaben, Blue 1

Questions or comments?

1-800-558-6684

"The ADA Council on Scientific Affairs'

Acceptance of Plak Smacker® Great White

Shark Fluoride Gel Toothpaste 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® 00181

Corona, CA 92879                         REV1

(800) 558-6684 www.plaksmacker.com

Principal Display Panel

PLAK SMACKER®

GREAT WHITE

SHARK

NO

SUGAR

ADDED

ADA

ACCEPTED

American Dental Association

COOL BERRY FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2 OZ (120G)

Plak Smacker

Plak Smacker

Sodium Fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55346-0718
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.4 mg

Inactive Ingredients

Ingredient Name Strength
sorbitol
water
HYDRATED SILICA
POLYETHYLENE GLYCOL 300
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
POLYETHYLENE GLYCOL 1450
saccharin sodium
METHYLPARABEN
PROPYLPARABEN
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-0718-2 120 in 1 TUBE
2 NDC:55346-0718-1 24 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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