DINOSAUR GEL- toothpaste gel, dentifrice
DSC Laboratories 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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Dinosaur Toothpaste

Active Ingredient:

Sodium Fluoride....0.24%

Purpose:

Anticavity

Use:

Aids in the prevention of cavities

WARNINGS:

Keep Out of Reach of children under 6 years of age

If you accidently swallow more than used for brushing, seek professional assistance of 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, D and C Red No.33

DINOSAUR TOOTHPASTE 120g TUBE

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Dinosaur Anti-Cavity Fluoride Gel Toothpaste
Net Wt. 4.2 oz (120g)
Distributed by: PLAK SMACKER
Riverside, CA 92503
(909) 734-3333
www.plaksmacker.com

DINOSAUR TOOTHPASTE 120g TUBE

DINOSAUR GEL
toothpaste gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52316-190
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52316-190-85	24 g in 1 TUBE; Type 0: Not a Combination Product	07/19/1999	10/01/2012
2	NDC:52316-190-42	120 g in 1 TUBE; Type 0: Not a Combination Product	07/19/1999	10/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/19/1999	10/01/2012

Labeler - DSC Laboratories Inc. (097807374)

Name	Address	ID/FEI	Business Operations
Establishment
DSC Laboratories Inc.		097807374	manufacture(52316-190)

Revised: 10/2016

Document Id: 5f1152aa-5f84-df06-e053-2991aa0a0bdd

Set id: ae318a9a-3a80-4440-bc06-74da6808dddc

Version: 4

Effective Time: 20161007

DSC Laboratories Inc.