Manufacturing Establishments (1)
Fulijaya Manufacturing Sdn. Bhd
Fulijaya Manufacturing Sdn. Bhd
652087115
Products (1)
Made by Dentists Enamel Rebuilding Professional
62776-003
M022
OTC Monograph Drug (C200263)
DENTAL
June 23, 2025
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.
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.
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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient:
Potassium Nitrate 5.0%
Sodium Fluoride 0.24% (0.15% w/v fluoride ion)
Purpose
Antisensitivity
Anticavity
OTC - QUESTIONS SECTION
Questions or comments?
+ 1 (646) 980-6461
SPL UNCLASSIFIED SECTION
Drug Facts
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