Plak Toothpaste - shark berry

Drug Labeling and Warnings

Drug Details [pdf]

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.

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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

NO

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 55346-0718
Route of AdministrationORAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRY (Cool Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55346-0718-2120 g in 1 TUBE; Type 0: Not a Combination Product12/31/200710/31/2019
2NDC: 55346-0718-124 g in 1 TUBE; Type 0: Not a Combination Product12/31/200710/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/31/200710/31/2019
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