MADE BY DENTISTS ULTRA WHITENING PROFESSIONAL- sodium fluoride paste

Made by Dentists Ultra Whitening Professional by

Drug Labeling and Warnings

Made by Dentists Ultra Whitening 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:

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

Purpose

Anticavity 

Use:

Aids in the prevention of cavities.

Warnings:

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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing), and only use a pea size amount.
• Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients:

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

Questions or comments?

+ 1 (646) 980-6461

Label

Label: 62776-005-02

INGREDIENTS AND APPEARANCE

MADE BY DENTISTS ULTRA WHITENING PROFESSIONAL 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62776-005
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62776-005-01	1 in 1 CARTON	01/01/2024
1		120 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 62776-005-02	1 in 1 CARTON	02/22/2024
2		20 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	M021	01/01/2024

Labeler - Fulijaya Manufacturing Sdn. Bhd (652087115)

Establishment
Name	Address	ID/FEI	Business Operations
Fulijaya Manufacturing Sdn. Bhd		652087115	manufacture(62776-005)