MADE BY DENTISTS ENAMEL REBUILDING PROFESSIONAL- potassium nitrate, sodium fluoride paste

Made by Dentists Enamel Rebuilding Professional by

Drug Labeling and Warnings

Made by Dentists Enamel Rebuilding Professional by is a Otc medication manufactured, distributed, or labeled by Fulijaya Manufacturing Sdn. Bhd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient:

Potassium Nitrate 5.0%

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

Purpose

Antisensitivity

Anticavity 

Use:

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

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.

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:

Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

Questions or comments?

+ 1 (646) 980-6461

Label

INGREDIENTS AND APPEARANCE

MADE BY DENTISTS ENAMEL REBUILDING PROFESSIONAL 
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62776-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62776-003-01	1 in 1 CARTON	01/01/2024
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/01/2024

Labeler - Fulijaya Manufacturing Sdn. Bhd (652087115)

Establishment
Name	Address	ID/FEI	Business Operations
Fulijaya Manufacturing Sdn. Bhd		652087115	manufacture(62776-003)