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DRUG FACTS
Manufactured & Dist. by Health and Natural Beauty USA Corp.
Piscataway, NJ 08854
Sensitivity Relief Fluoride Free Paste, Dentifrice
FDA Label NDC 63404-2105
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 Sensitivity Relief Fluoride Free (NDC 63404-2105). 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, uses, otc - keep out of reach of children, otc - ask doctor, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Potassium Nitrate 5%
Purpose
Antihypersensitivity
Uses
Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Ask Doctor
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.
Otc - Do Not Use
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, Glycerin, Xylitol, Hydrated Silica, Calcium Carbonate, Zemea from Non-GMO Corn (1,3-Propanediol), Natural Peppermint Oil, Xanthan Gum, Cocamidopropyl Hydroxysultaine, Zinc Citrate, Zinc Oxide, Black Seed Oil (Nigella Sativa), Stevia Rebaudiana Extract, Sodium Lauryl Sulfoacetate (LAL), Acacia Gum
Questions Or Comments?
Call 1-844-346-2872 www.sprinjene.com
Principal Display Panel - 100 G Tube Carton
SprinJene®+Sensitivity
Natural Relief
FLUORIDE FREE
TOOTHPASTE
with BLACK SEED OIL (Nigella sativa) & Zinc
HELPS RELIEVE TEETH SENSITIVITY | FRESHENS BREATH
HELPS DRY MOUTH | CLEANS TEETH
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
GLUTEN-FREE
ICS
CERTIFIED
GLUTEN FREE
KOSHER
CRUELTY FREE
Certified
Principal Display Panel (100 g Tube Carton)
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