Sprinjene™

Sprinjene™
SPL v3
SPL
SPL Set ID 919f6f51-6c43-4f1c-9bc7-029bf76c0e68
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 Glycerin Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Zinc Citrate Guizotia Abyssinica Seed Oil Sodium Pyrophosphate Xanthan Gum Saccharin Sodium Mica Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
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

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, sorbitol, glycerin, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, zinc citrate, black seed oil, xanthan, sodium saccharin, mica, FD&C Blue No. 1, FD&C Yellow No. 5

Questions Or Comments?

Call toll free 1-844-3-462872

www.sprinjene.com

Principal Display Panel 130 G Tube Carton

NEW

SprinJene

Fluoride Toothpaste

Bursting with the

unique benefits of


Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

Fresh Boost Gel

NET WT 4.6 OZ (130 g)

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.


Structured Label Content

Use

Helps in the prevention of caries

Section 42229-5 (42229-5)

Drug Facts

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, sorbitol, glycerin, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, zinc citrate, black seed oil, xanthan, sodium saccharin, mica, FD&C Blue No. 1, FD&C Yellow No. 5

Questions Or Comments? (Questions or comments?)

Call toll free 1-844-3-462872

www.sprinjene.com

Principal Display Panel 130 G Tube Carton (PRINCIPAL DISPLAY PANEL - 130 g Tube Carton)

NEW

SprinJene

Fluoride Toothpaste

Bursting with the

unique benefits of


Black Seed Oil

CERTIFIED VEGAN

VEGAN.ORG

Fresh Boost Gel

NET WT 4.6 OZ (130 g)

Keep Out of Reach of Children Under 6 Years of Age (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.


Advanced Ingredient Data


Raw Label Data

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