Sprinjene Paste, Dentifrice
FDA Label NDC 63404-0201

9 label sections · Submitted to the FDA by Health And Natural Beauty Usa Corp · 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.

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Other

DRUG FACTS

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

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.14 W/V Fluoride Ion)

Purpose

Anticavity

Use

Aids in the prevention of dental 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 under 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

Water, Hydrated Silica, Glycerin, Xylitol, 1,3 Propanediol (Zemea - made from non GMO corn), Natural Peppermint Oil, Xanthan Gum, Precipitated Natural Calcium Carbonate, Zinc Citrate, Cocamidopropyl Hydroxysultaine, Zinc Oxide, Nigella Sativa (Black Seed Oil), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Tetrasodium Pyrophosphate, Acacia Gum.

Principal Display Panel - 100 G Tube Carton

SprinJene®
Natural

CAVITY PROTECTION
TOOTHPASTE

with BLACK SEED OIL (Nigella Sativa) & ZINC
REMINERALIZES ENAMEL | CLEANS TEETH
FRESHENS BREATH

NET WT 3.5 OZ (100 g)

Made in USA

To accommodate
the needs of
various lifestyles.

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%
USDA BIOPREFERRED

CERTIFIED VEGAN
VEGAN.ORG
VEGAN

CRUELTY FREE

KOSHER

GF™ CERTIFIED
GLUTEN FREE

Certified

Principal Display Panel (100 g Tube Carton)

Principal Display Panel (100 g Tube Carton)

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