DENTISSE- sodium fluoride paste, dentifrice

Dentisse by

Drug Labeling and Warnings

Dentisse by is a Otc medication manufactured, distributed, or labeled by Dentisse, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sodium Fluoride 0.243%

Purpose

Anticavity Toothpaste

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidently 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 preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supevision.
• Children under 2 years of age, constult a dentist or a doctor.

Other information

For your protection, this tube has a foil seal under the cap.

Inactive ingredients

refined kaolin clay, purified water, sorbitol, vegetable glycerin, sodium laurly sulfate, cellulose gum, natural mint flavors, xylitol, bentonite clay, sodium citrate, sodium phosphate, sucralose

Questions or comments?

Manufactured for Dentisse, Inc.

1-888-672-5744

Fort Wayne, IN 46825

Visit www.dentisse.com

SPL UNCLASSIFIED SECTION

Contains no saccharin, artificial preservatives, animal ingredients, artificial colors or flavors.

Made in USA

Principle Display Panel

DENTISSE ®

PRO

Natural Reflection™

Anticavity Fluoride

Toothpaste with Xylitol

Premium Polishing and Whitening Formula

Power by Kaodent™

Radiant Mint

Net Wt. 3.2 oz. (91 g)

INGREDIENTS AND APPEARANCE

DENTISSE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70683-0703
Route of Administration	DENTAL, ORAL

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

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
XYLITOL (UNII: VCQ006KQ1E)
SUCRALOSE (UNII: 96K6UQ3ZD4)
MENTHOL (UNII: L7T10EIP3A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70683-0703-2	91 g in 1 TUBE; Type 0: Not a Combination Product	02/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/13/2014

Labeler - Dentisse, Inc. (078398940)