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Approved
Approval ID

178d7538-c178-b8ca-e063-6394a90a7d33

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

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
NDC Product Code62776-003
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
POTASSIUM NITRATE, SODIUM FLUORIDE
Product Specifications
Route of AdministrationDENTAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (14)

CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUSInactive
Code: 9SW4PFD2FZ
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
POTASSIUM NITRATEActive
Quantity: 50 mg in 1 g
Code: RU45X2JN0Z
Classification: ACTIB
SODIUM FLUORIDEActive
Quantity: 1.5 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/22/2024

Label

Labell.jpgLabel2.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/22/2024

Use:

Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/22/2024

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/22/2024

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antisensitivity

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 2/22/2024

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

LOINC: 34068-7Updated: 2/22/2024

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

LOINC: 51727-6Updated: 2/22/2024

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

LOINC: 53413-1Updated: 2/22/2024

Questions or comments?

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Made by Dentists Enamel Rebuilding Professional - FDA Drug Approval Details