Made by Dentists Enamel Rebuilding Professional
Made by Dentists Enamel Rebuilding Professional
178d7538-c178-b8ca-e063-6394a90a7d33
HUMAN OTC DRUG LABEL
Jun 23, 2025
Fulijaya Manufacturing Sdn. Bhd
DUNS: 652087115
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
POTASSIUM NITRATE, SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label


INDICATIONS & USAGE SECTION
Use:
Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient:
Potassium Nitrate 5.0%
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Antisensitivity
Anticavity
WARNINGS SECTION
Warnings:
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.
Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 INGREDIENT SECTION
Inactive ingredients:
Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol
OTC - QUESTIONS SECTION
Questions or comments?
+ 1 (646) 980-6461
