SPRINJENE WHITE BOOST- sodium fluoride paste, dentifrice

SprinJene by

Drug Labeling and Warnings

SprinJene by is a Otc medication manufactured, distributed, or labeled by Health and Natural Beauty USA Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

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

Purpose

Anticavity

Use

Helps in the prevention of caries

Warnings

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.

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

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Dist. by:
Health and Natural Beauty USA Corp
Piscataway, NJ 08854

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

INGREDIENTS AND APPEARANCE

SPRINJENE   WHITE BOOST
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-1116
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Glycerin (UNII: PDC6A3C0OX)
Sorbitol (UNII: 506T60A25R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Zinc Oxide (UNII: SOI2LOH54Z)
Guizotia Abyssinica Seed Oil (UNII: QX0GL46299)
Sodium Pyrophosphate (UNII: O352864B8Z)
Titanium Dioxide (UNII: 15FIX9V2JP)
Zinc Citrate (UNII: K72I3DEX9B)
Xanthan Gum (UNII: TTV12P4NEE)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Mint/Clove)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-1116-1	1 in 1 CARTON
1		142 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 63404-1116-2	1 in 1 CARTON
2		42 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	10/10/2014

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beauty USA Corp		079129688	MANUFACTURE(63404-1116)