SENSITIVITY AND GUM WITH CAVITY PROTECTION- potassium nitrate and sodium fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENT	PURPOSE
Sodium Monofluorophosphate 0.76% (0.14 W/V Fluoride Ion)	Anticavity
Potassium Nitrate 5%	Antihypersensitivity

USE

• 1) Aids in prevention of cavities.
• 2) Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

WARNINGS

Keep out of reach of children. "Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor."

DIRECTIONS

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft-bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENTS

Water (Aqua), Glycerin, Hydrated Silica, Xylitol, 1,3 - Propanediol (Zemea - made from non-GMO Corn), Natural Peppermint Oil, Cocamidopropyl Hydroxysultaine (from Coconut Oil), Zinc Citrate, Xanthan Gum, Nigella Sativa (Black Seed Oil), Sodium Hydroxide, TiO2, Stevia Rebaudiana Extract, Acacia Gum, Echinacea Purpurea (Coneflower Extract), Commiphora Myrrha (Myrrh Oil), Rosmarinus Officinalis (Rosemary Oil), Thymus Vulgaris Oil (Thyme ), Eugenia Caryophyllus (Clove Bud Oil), Cocos Nucifera (Coconut Oil), Zingiber Officinale (Ginger Oil), Hydrastis Canadensis (Goldenseal Root), Melaleuca Alternifolia (Tea Tree Oil), Hippophae Rhamnoides (Sea Buckthorn Fruit Oil), Punica Granatum (Pomegranate Seed Oil)

Questions or comments?

Call 1-844-346-2872 www.sprinjene.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 142 g Tube Carton

SprinJene
Natural®

SENSITIVITY & GUM

CAVITY PROTECTION

TOOTHPASTE

BURSTING WITH THE
UNIQUE BENEFITS OF
BLACK SEED OIL
AND ZINC

• ✓ POMEGRANATE
• ✓ TEA TREE OIL
• ✓ THYME

FREE FROM:
SLS DYE PRESERVATIVES

NATURAL PEPPERMINT OIL

NET WT 5 OZ (142g)

CERTIFIED:

CERTIFIED VEGAN
VEGAN.ORG
VEGAN

GLUTEN-FREE
ICS
CERTIFIED
GLUTEN FREE

USDA
CERTIFIED
BIOBASED
PRODUCT
PRODUCT 100%
USDA BIOPREFERRED

KOSHER

CRUELTY FREE

INGREDIENTS AND APPEARANCE

SENSITIVITY AND GUM WITH CAVITY PROTECTION 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63404-2210
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate ion - UNII:T93E9Y2844)	Potassium Nitrate	50 mg  in 1 g
Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O)	fluoride ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
Hydrated silica (UNII: Y6O7T4G8P9)
PROPANEDIOL (UNII: 5965N8W85T)
ACACIA (UNII: 5C5403N26O)
XANTHAN GUM (UNII: TTV12P4NEE)
Zinc Citrate (UNII: K72I3DEX9B)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
Sodium Hydroxide (UNII: 55X04QC32I)
COCONUT OIL (UNII: Q9L0O73W7L)
GINGER OIL (UNII: SAS9Z1SVUK)
GOLDENSEAL (UNII: ZW3Z11D0JV)
TEA TREE OIL (UNII: VIF565UC2G)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63404-2210-1	1 in 1 CARTON	01/01/2020
1		142 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 DRUG	M022	01/01/2020

Labeler - Health and Natural Beauty USA Corp (079129688)

Establishment
Name	Address	ID/FEI	Business Operations
Health and Natural Beauty USA Corp		079129688	MANUFACTURE(63404-2210)