ORAZEN- sodium monofluorophosphate paste

Orazen Kids Smile Kit by

Drug Labeling and Warnings

Orazen Kids Smile Kit by is a Otc medication manufactured, distributed, or labeled by Orazen Inc, YANGZHOU SION COMMODITY CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                               

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose
Anti-Cavity Toothpaste

INDICATIONS & USAGE

Use: Helps prevent against cavities

KEEP OUT OF REACH OF CHILDREN

 Keep out of reach of children under 6 years of age.

WARNINGS

Warnings: If you accidentally swallow more than used for brushing,get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions:adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist

INACTIVE INGREDIENT

Inactive Ingredients: Sorbitol, Hydrated Silica, Water, Peg-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Trisodium Phospate, Mica, Sodium Benzoate, CI 73015

QUESTIONS

DESCRIPTION

Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

Info@orazeninc.com

Made in China/Hecho en China

Fabrique en Chine

PRINCIPAL DISPLAY PANEL

Ora-Zen Anticavity Toothpaste

Bubblegum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORAZEN 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71927-102
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICA (UNII: V8A1AW0880)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM PHOSPHIDE (UNII: A360RQX9W2)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71927-102-01	1 in 1 POUCH	04/01/2023
1		28 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 not final	part356	04/01/2023

Labeler - Orazen Inc (080916640)

Registrant - Orazen Inc (080916640)

Establishment
Name	Address	ID/FEI	Business Operations
YANGZHOU SION COMMODITY CO		546806042	manufacture(71927-102)