DENTEK KIDS ANTICAVITY FLUORIDE LOONEY TUNES BUBBLEGUM BLAST- sodium fluoride paste, dentifrice

DenTek Kids Anticavity Fluoride by

Drug Labeling and Warnings

DenTek Kids Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by DenTek Oral Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

toothpaste tube label

Active Ingredients

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

Purpose

Anticavity

Indications and Use

Use: Helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 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

Questions? 1-800-433-6835

Keep Out of Reach of Children

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

INGREDIENTS AND APPEARANCE

DENTEK KIDS ANTICAVITY FLUORIDE  LOONEY TUNES BUBBLEGUM BLAST
sodium fluoride 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	0.0964 g  in 76.5 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	42.075 g  in 76.5 g
WATER (UNII: 059QF0KO0R)	15.34 g  in 76.5 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)	15.3 g  in 76.5 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	1.3 g  in 76.5 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)	0.918 g  in 76.5 g
SODIUM PHOSPHATE (UNII: SE337SVY37)	0.38 g  in 76.5 g
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)	0.176 g  in 76.5 g
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.0765 g  in 76.5 g

Product Characteristics
Color	red (CI 45430 (FD&C Red No. 3))	Score
Shape		Size
Flavor	BUBBLE GUM (Proprietary blend)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-498-01	76.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/01/2014

Labeler - DenTek Oral Care, Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)