dentisse

dentisse
SPL v3
SPL
SPL Set ID 326b290a-9bd2-468e-e054-00144ff8d46c
Routes
dental oral
Published
Effective Date 2020-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
kaolin bentonite sodium lauryl sulfate water sorbitol glycerin carboxymethylcellulose sodium sodium phosphate, dibasic xylitol sucralose menthol sodium citrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-02-13

Purpose

Anticavity Toothpaste

Description

Sodium Fluoride 0.243%


Medication Information

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity Toothpaste

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

Description

Sodium Fluoride 0.243%

Principal Display Panel

DENTISSE ®

Anticavity Fluoride

Toothpaste

Natural Clay Based Whitening

Radiant Mint

Net Wt. 3.2 oz. (91 g)

Active Ingredient

Sodium Fluoride 0.243%

Questions Or Comments?

Manufactured for Dentisse, Inc.

1-260-444-3046 Fort Wayne, IN 46825

www.dentisse.com


Structured Label Content

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.

Uses

Aids in the prevention of dental cavities.

Purpose

Anticavity Toothpaste

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 (Other information)

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

Inactive Ingredients (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

Principal Display Panel

DENTISSE ®

Anticavity Fluoride

Toothpaste

Natural Clay Based Whitening

Radiant Mint

Net Wt. 3.2 oz. (91 g)

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

Questions Or Comments? (Questions or comments?)

Manufactured for Dentisse, Inc.

1-260-444-3046 Fort Wayne, IN 46825

www.dentisse.com


Advanced Ingredient Data


Raw Label Data

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