MedPath
FDA Approval

Made by Dentists Enamel Rebuilding Professional

Fulijaya Manufacturing Sdn. Bhd (DUNS: 652087115)

June 23, 2025

HUMAN OTC DRUG LABEL

Potassium nitrate(50 mg in 1 g)
Sodium fluoride(1.5 mg in 1 g)

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

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KXClass: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9Class: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28Class: IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
Code: RU45X2JN0ZClass: ACTIBQuantity: 50 mg in 1 g
Code: 8ZYQ1474W7Class: ACTIMQuantity: 1.5 mg in 1 g

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Labell.jpgLabel2.jpg


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


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