Sprinjene™

Sprinjene™
SPL v3
SPL
SPL Set ID 8c401bea-0148-46a0-bbb3-80c17f9e8e3e
Route
DENTAL
Published
Effective Date 2015-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Glycerin Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Zinc Oxide Guizotia Abyssinica Seed Oil Sodium Pyrophosphate Titanium Dioxide Zinc Citrate Xanthan Gum Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-10-10

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Helps in the prevention of caries

Section 42229-5

Drug Facts

Section 50565-1

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

Supervise children as necessary until capable of using without supervision

Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician.

Children under 2 to 6 years instruct in good brushing and rinsing habbits (to minimize swallowing).

Children under 2 years do not use unless directed by a dentist or physician.

Active Ingredient

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Inactive Ingredients

Water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, zinc oxide, tetrasodium pyrophosphate, black seed oil, zinc citrate, titanium dioxide, xanthan gum, sodium saccharin

Questions Or Comments?

Call toll free 1-844-3-462872

www.sprinjene.com

Principal Display Panel 142 G Tube Carton

NEW

SprinJene

Fluoride Toothpaste

NET WT 5.0 OZ (142 g)

Bursting with the

unique benefits of


Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

White Boost Paste


Structured Label Content

Use

Helps in the prevention of caries

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

Directions

Supervise children as necessary until capable of using without supervision

Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day as directed by a dentist or physician.

Children under 2 to 6 years instruct in good brushing and rinsing habbits (to minimize swallowing).

Children under 2 years do not use unless directed by a dentist or physician.

Active Ingredient

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Inactive Ingredients

Water, hydrated silica, glycerin, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, zinc oxide, tetrasodium pyrophosphate, black seed oil, zinc citrate, titanium dioxide, xanthan gum, sodium saccharin

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-3-462872

www.sprinjene.com

Principal Display Panel 142 G Tube Carton (PRINCIPAL DISPLAY PANEL - 142 g Tube Carton)

NEW

SprinJene

Fluoride Toothpaste

NET WT 5.0 OZ (142 g)

Bursting with the

unique benefits of


Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

White Boost Paste


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)