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Shark Toothpaste

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 2.4mg in 1g
Labeler: DSC Laboratories, Div. of DSC Products Inc.
NDC Code: 52316-191

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.

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 and C Blue No.1,

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 
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52316-191
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
WATER 
SODIUM SILICATE 
CARBOXYMETHYLCELLULOSE SODIUM 
POLYETHYLENE GLYCOL 1450 
POLYETHYLENE GLYCOL 300 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
METHYLPARABEN SODIUM 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:52316-191-8524 g in 1 TUBE
2NDC:52316-191-42120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/19/1999
Labeler - DSC Laboratories, Div. of DSC Products Inc. (097807374)
Establishment
NameAddressID/FEIOperations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture

Revised: 05/2010
Document Id: 30d0497b-2eda-4b9f-9736-89ed3f60b795
Set id: 8d2c55cf-3b91-4dc8-8c31-02d2f1958bda
Version: 2
Effective Time: 20100510
 
DSC Laboratories, Div. of DSC Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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