Label: ORAZEN- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 13, 2023

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  • 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

    Tube Art

  • INGREDIENTS AND APPEARANCE
    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)
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