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DenTek Looney Tunes Kids Bubblegum Blast

Dosage form: paste, dentifrice
Ingredients: SODIUM FLUORIDE 0.09639g in 76.5g
Labeler: DenTek Oral Care, Inc.
NDC Code: 60630-498

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.

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

DENTEK LOONEY TUNES KIDS  BUBBLEGUM BLAST
fluoride toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-498
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.09639 g  in 76.5 g
Inactive Ingredients
Ingredient NameStrength
WATER61.1618 g  in 76.5 g
HYDRATED SILICA15.3 g  in 76.5 g
SODIUM PHOSPHATE0.3825 g  in 76.5 g
SACCHARIN SODIUM0.176 g  in 76.5 g
CARBOXYMETHYLCELLULOSE0.918 g  in 76.5 g
ERYTHROSINE SODIUM ANHYDROUS0.0008 g  in 76.5 g
SODIUM LAURYL SULFATE1.3005 g  in 76.5 g
SODIUM HYDROXIDE0.0765 g  in 76.5 g
SORBITOL42.075 g  in 76.5 g
Packaging
#Item CodePackage Description
1NDC:60630-498-0176.5 g in 1 TUBE
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/FEIOperations
DenTek Oral Care, Inc.153818646label(60630-498)
Establishment
NameAddressID/FEIOperations
Goran Pharma Pvt. Ltd.862174088manufacture(60630-498)

Revised: 02/2016
 
DenTek Oral Care, 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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