SHARK- toothpaste paste, dentifrice 
DSC Laboratories, Div. of DSC Products 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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Drug Facts:

Active Ingredient:

Sodium Fluoride....0.24%

Purpose:

Anticavity

Use:

Aids in the prevention of cavities

WARNINGS:

KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

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 physician.

Children 2 to 6 years. Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

Children under 2 years. Ask a  dentist or a physician.

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Polyethylene Glycol 540, Sodium Carboxymethylcellulose, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Sodium Methylparaben, Propylparaben, FD&C Blue No. 1

Keep out of reach of children under 6 years of age

If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

SHARK TOOTHPASTE 120G TUBE

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

Shark Anti-Cavity Fluoride Toothpaste

Net. Wt. 4.2 oz (120g)

Distributed by: PLAK SMACKER

Riverside, CA 92503

(909) 734-3333

www.plaksmacker.com


SHARK TOOTHPASTE 120G TUBE


SHARK 
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52316-191
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0905 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SODIUM SILICATE (UNII: IJF18F77L3)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52316-191-8524 g in 1 TUBE; Type 0: Not a Combination Product07/19/199910/01/2012
2NDC:52316-191-42120 g in 1 TUBE; Type 0: Not a Combination Product07/19/199910/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/19/199910/01/2012
Labeler - DSC Laboratories, Div. of DSC Products Inc. (097807374)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture(52316-191)

Revised: 10/2016
 
DSC Laboratories, Div. of DSC Products Inc.