DENTEK LOONEY TUNES KIDS BUBBLEGUM BLAST- fluoride toothpaste paste, dentifrice

DenTek Looney Tunes Kids by

Drug Labeling and Warnings

DenTek Looney Tunes Kids by is a Otc medication manufactured, distributed, or labeled by DenTek Oral Care, Inc., Goran Pharma Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Sodium Fluoride 0.22% (0.126% w/v Fluoride Ion)

PURPOSE

Purpose:

Anticavity

INDICATIONS & USAGE

Use:

Helps protect against cavities

WARNINGS

Warnings:

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age.

DOSAGE & ADMINISTRATION

Directions: . Adults and children 2 years of age and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist .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 physician

INACTIVE INGREDIENT

Inactive Ingredients: Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3).

QUESTIONS

Questions? 1-800-433-6835

toothpaste tube label

INGREDIENTS AND APPEARANCE

DENTEK LOONEY TUNES KIDS  BUBBLEGUM BLAST
fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60630-498
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.09639 g  in 76.5 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	61.1618 g  in 76.5 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)	15.3 g  in 76.5 g
SODIUM PHOSPHATE (UNII: SE337SVY37)	0.3825 g  in 76.5 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.176 g  in 76.5 g
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)	0.918 g  in 76.5 g
ERYTHROSINE SODIUM ANHYDROUS (UNII: 8TL7LH93FM)	0.0008 g  in 76.5 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	1.3005 g  in 76.5 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0765 g  in 76.5 g
SORBITOL (UNII: 506T60A25R)	42.075 g  in 76.5 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-498-01	76.5 g in 1 TUBE; Type 0: Not a Combination Product	02/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/28/2014

Labeler - DenTek Oral Care, Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)

Establishment
Name	Address	ID/FEI	Business Operations
DenTek Oral Care, Inc.		153818646	label(60630-498)

Establishment
Name	Address	ID/FEI	Business Operations
Goran Pharma Pvt. Ltd.		862174088	manufacture(60630-498)