DENTEK LOONEY TUNES KIDS BUBBLEGUM BLAST- fluoride toothpaste paste, dentifrice 
DenTek Oral Care, 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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DenTek Looney Tunes Kids Anticavity Fluoride Toothpaste

Active Ingredients:

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

Purpose:

Anticavity

Use:

Helps protect against cavities

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.

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 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? 1-800-433-6835

toothpaste tube label

Looney toothpaste tube label

DENTEK LOONEY TUNES KIDS  BUBBLEGUM BLAST
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-498
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.09639 g  in 76.5 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60630-498-0176.5 g in 1 TUBE; Type 0: Not a Combination Product02/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/28/2014
Labeler - DenTek Oral Care, Inc. (153818646)
Registrant - DenTek Oral Care, Inc. (153818646)
Establishment
NameAddressID/FEIBusiness Operations
DenTek Oral Care, Inc.153818646label(60630-498)
Establishment
NameAddressID/FEIBusiness Operations
Goran Pharma Pvt. Ltd.862174088manufacture(60630-498)

Revised: 2/2016
Document Id: 2b437c41-f6db-1da3-e054-00144ff88e88
Set id: 2b437c41-f6da-1da3-e054-00144ff88e88
Version: 3
Effective Time: 20160208
 
DenTek Oral Care, Inc.