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DRUG FACTS
Manufactured and Dist by: Health and Natural Beauty USA Corp, Piscataway, NJ 08854
Sensitivity And Gum With Cavity Protection Paste, Dentifrice
FDA Label NDC 63404-2210
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 And Gum With Cavity Protection (NDC 63404-2210). 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, otc - purpose, use, otc - keep out of reach of children, directions, inactive ingredients, questions or comments?, principal display panel - 142 g tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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.
Otc - Keep Out Of Reach Of Children
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
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
Principal Display Panel (142 g Tube Carton)
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