PLAK SMACKER- sodium fluoride paste, dentifrice
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.

----------

Plak Toothpaste - shark berry

Active Ingredient

Sodium Fluoride 0.24%

(0.14% w/v fluoride ion)

Purpose

Anticavity toothpaste

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

Principal Display Panel

PLAK SMACKER®

GREAT WHITE

SHARK

SUGAR

ADDED

COOL BERRY FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2 OZ (120G)

tube

PLAK SMACKER
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55346-0718
Route of Administration	ORAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Cool Berry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55346-0718-2	120 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2007	10/31/2019
2	NDC:55346-0718-1	24 g in 1 TUBE; Type 0: Not a Combination Product	12/31/2007	10/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/31/2007	10/31/2019

Labeler - Dental Technologies, Inc (148312838)

Revised: 12/2017

Document Id: 605132f8-920f-6e5f-e053-2991aa0a71b2

Set id: 0de9d469-1a66-4b40-b7c9-dcfa47e8e244

Version: 3

Effective Time: 20171214

Dental Technologies, Inc