Sprinjene®

Sprinjene®
SPL v3
SPL
SPL Set ID 9be87bcd-403a-4d7e-8ded-9833249565d1
Route
DENTAL
Published
Effective Date 2023-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Xylitol Erythritol Poloxamer 407 Cocamidopropyl Betaine Carboxymethylcellulose Sodium, Unspecified Zinc Citrate Zinc Oxide Sodium Lauryl Sulfoacetate Nigella Sativa Seed Oil Titanium Dioxide Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-01

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Helps in the prevention of cavities

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 w ithout 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 2-6 years old instruct in good brushing and rinsing habits (to minimize swallowing.)

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

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.15% W/V fluoride ion)

Inactive Ingredients

Aqua, hydrated silica, sorbitol, glycerin, xylitol, erythritol, poloxamer 407, cocamidopropyl betaine, flavor, cellulose gum, zinc citrate, zinc oxide, sodium lauryl sulfoacetate, nigella sativa oil (black seed oil), titanium dioxide, xanthan gum

Questions Or Comments?

Call toll free 1-844-346-2872

www.sprinjene.com

Principal Display Panel 142 G Tube Carton

SprinJene®

Fluoride Toothpaste

NET WT 5 OZ (142g)

Bursting with the

unique benefits of

Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

Health Boost Paste


Structured Label Content

Use

Helps in the prevention of cavities

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 w ithout 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 2-6 years old instruct in good brushing and rinsing habits (to minimize swallowing.)

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

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.15% W/V fluoride ion)

Inactive Ingredients

Aqua, hydrated silica, sorbitol, glycerin, xylitol, erythritol, poloxamer 407, cocamidopropyl betaine, flavor, cellulose gum, zinc citrate, zinc oxide, sodium lauryl sulfoacetate, nigella sativa oil (black seed oil), titanium dioxide, xanthan gum

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-346-2872

www.sprinjene.com

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

SprinJene®

Fluoride Toothpaste

NET WT 5 OZ (142g)

Bursting with the

unique benefits of

Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

Health Boost Paste


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)