PLAK SMACKER- sodium fluoride paste, dentifrice 
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

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®

NO

SUGAR

ADDED

DINOSAUR TM

BUBBLE

GUM

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:0273-0719
Route of AdministrationORAL, DENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 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
FlavorBUBBLE GUM (Bubble Gum) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-0719-20120 g in 1 TUBE; Type 0: Not a Combination Product12/31/2007
2NDC:0273-0719-1024 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
Document Id: 5b88e4ea-9e6b-42a6-ac6b-7fb2073f7619
Set id: 4408868c-905a-28eb-e054-00144ff8d46c
Version: 2
Effective Time: 20180123
 
Young Dental Manufacturing Co 1, LLC.