Sprinjene
FDA Label NDC 63404-6319

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 63404-6319). 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, principal display panel - 142 gm tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

MANUFACTURED AND DIST BY : HEALTH AND NATURAL
BEAUTY USA CORP PISCATAWAY, NJ 08854

Active Ingredient

SODIUM FLUORIDE 0.243% (0.14 W/V FLUORIDE ION

Purpose

ANTICAVITY

Use

HELPS IN THE PREVENTION OF CAVITIES. HELPS REMOVE SURFACE STAINS WITH REGULAR BRUSHING, AND HELPS PREVENT PLAQUE BUILDUP

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. INSTRUCT CHILDREN 2 TO 6 YEARS 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 (AQUA), HYDRATED SILICA, XYLITOL, GLYCERIN, 1,3 - PROPANEDIOL (ZEMEA - MADE FROM NON-GMO CORN), NATURAL PEPPERMINT OIL, ZINC CITRATE, XANTHAN GUM, SODIUM LAURYL SULFOACETATE (LAL), NIGELLA SATIVA (BLACK SEED OIL), ZINC OXIDE, STEVIA REBAUDIANA EXTRACT, TIO2, ACACIA GUM, PUNICA GRANATUM SEED OIL (POMEGRANATE), THYMUS VULGARIS OIL (THYME), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL

Principal Display Panel - 142 Gm Tube Carton

SprinJene
Natural®

TOTAL CARE
CAVITY PROTECTION
TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF
BLACK SEED OIL AND ZINC

NET WT 5OZ (142GM)

  • WHITENING
  • REMINERALIZES ENAMEL
  • FRESHENS BREATH
  • HELPS DRY MOUTH
  • SLS FREE
  • PRESERVATIVE FREE
  • DYE FREE
  • NATURAL PEPPERMINT OIL

    • USDA
    CERTIFIED
    BIOBASED
    PRODUCT
    PRODUCT 100%

    CERTIFIED VEGAN
    VEGAN.ORG

    GLUTEN-FREE
    CERTIFIED

    Principal Display Panel (142 GM Tube Carton)

    Principal Display Panel (142 GM Tube Carton)

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