Sprinjene Natural®

Sprinjene Natural®
SPL v2
SPL
SPL Set ID 3cb23e36-0e8c-4172-b4ae-859b58a2739f
Route
DENTAL
Published
Effective Date 2025-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg)
Inactive Ingredients
Water Hydrated Silica Xylitol Glycerin Propanediol Zinc Citrate Xanthan Gum Sodium Lauryl Sulfoacetate Nigella Sativa Seed Oil Zinc Oxide Stevia Serrata Flower Oil Titanium Dioxide Acacia Pomegranate Thyme Oil Tea Tree Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-20

Description

DRUG FACTS

Purpose

ANTIHYPERSENSITIVITY


Medication Information

Purpose

ANTIHYPERSENSITIVITY

Description

DRUG FACTS

Use

HELPS REDUCE TOOTH AND GUM SENSITIVITY, HELPS REMOVE SURFACE STAINS WITH REGULAR BRUSHING, AND HELPS PREVENT PLAQUE BUILDUP

Section 42229-5

DRUG FACTS

Section 50565-1

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.

Active Ingredient

POTASSIUM NITRATE 5%

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®

SENSITIVITY & GUM

FLUORIDE FREE

TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF

BLACK SEED OIL AND ZINC

  • WHITENING
  • 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

NET WT 5OZ (142GM)


Structured Label Content

Use (USE)

HELPS REDUCE TOOTH AND GUM SENSITIVITY, HELPS REMOVE SURFACE STAINS WITH REGULAR BRUSHING, AND HELPS PREVENT PLAQUE BUILDUP

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

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.

Purpose (PURPOSE)

ANTIHYPERSENSITIVITY

Directions (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.

Active Ingredient (ACTIVE INGREDIENT)

POTASSIUM NITRATE 5%

Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL - 142 GM Tube Carton)

SprinJene

Natural®

SENSITIVITY & GUM

FLUORIDE FREE

TOOTHPASTE

BURSTING WITH THE UNIQUE BENEFITS OF

BLACK SEED OIL AND ZINC

  • WHITENING
  • 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

NET WT 5OZ (142GM)


Advanced Ingredient Data


Raw Label Data

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