ORAZEN- sodium monofluorophosphate paste 
Orazen Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Orazen Kids Anticavity Toothpaste

Active Ingredient                               

Sodium Monofluorophosphate 0.76%

Purpose
Anti-Cavity Toothpaste

Use: Helps prevent against cavities

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

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

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

Orazen

Orazen Inc

Somerset, NJ 08873

Questions 888-349-7897

Info@orazeninc.com

Made in China/Hecho en China

Fabrique en Chine

Ora-Zen Anticavity Toothpaste

Bubblegum

Tube Art

ORAZEN 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-102
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71927-102-011 in 1 POUCH04/01/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2023
Labeler - Orazen Inc (080916640)
Registrant - Orazen Inc (080916640)
Establishment
NameAddressID/FEIBusiness Operations
YANGZHOU SION COMMODITY CO546806042manufacture(71927-102)

Revised: 8/2023
Document Id: 02d3b8d7-921c-daed-e063-6294a90a5db6
Set id: fa5b6bd8-443f-79e7-e053-6394a90a5513
Version: 2
Effective Time: 20230813
 
Orazen Inc