Other
Drug Facts
Manufactured and Dist. by:
Health and Natural Beauty USA Corp.
Piscataway, NJ 08854
Sprinjene
FDA Label NDC 63404-0201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Health And Natural Beauty Usa Corp for the product Sprinjene (NDC 63404-0201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Monofluorophosphate: 0.76% (0.14% w/v fluoride ion)
Purpose
Anticavity
Use
Helps in the prevention of cavities.
Otc - Keep Out Of Reach Of Children
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 2 to 6 years instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years do not use unless directed by a dentist or physician.
Inactive Ingredients
Aqua, Xylitol, Glycerin, Silica, Calcium Carbonate, Acacia Gum, Corn Zemea (1,3-Propanediol), Vegetable Betaine (Cocamidopropyl Betaine), Flavor, Sodium Bicarbonate, Zinc Citrate, Guar Gum, Xanthan Gum, Black Seed Oil (Nigella sativa), Zinc Oxide, Stevia Rebaudiana Extract, Pectin.
Questions Or Comments?
Call 1-844-346-2872 www.sprinjene.com
Principal Display Panel - 99 G Tube Carton
SprinJene®
Natural
with Fluoride
TOOTHPASTE
with BLACK SEED OIL (Nigella sativa) & ZINC
CAVITY PROTECTION | REMINERALIZES ENAMEL | HELPS DRY MOUTH
NET WT 3.5 OZ (99 g)
Made in USA
To accommodate
the needs of
various lifestyles.
Certified:
CERTIFIED VEGAN
VEGAN.ORG
Vegan
GLUTEN-FREE
CERTIFIED
Gluten
Free
U
Kosher
HALAL
Halal
Principal Display Panel (99 g Tube Carton)
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