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Ora 2 stain clear (Sunstar Guangzhou Ltd.)

Available Formats

Dosage Form Package Information Links
PASTE 25 g in 1 TUBE (53050-001-01) Label Information
PASTE 40 g in 1 TUBE (53050-001-02) Label Information
PASTE 5 g in 1 TUBE (53050-001-03) Label Information

Complete Ora 2 stain clear Information

  • Active Ingredient

    Sodium Fluoride 0.1%


  • Purpose

    Anticavity toothpaste


  • Use

    aids in the prevention of dental decay


  • Warning

    If more than used for brushing is accidentally swallowed,get medical help or contact a Poison Control Center right away.


  • Directions

    adults and children 2 years and older

    Brush teeth thoroughly after meals or at least twice a day,or use as directed by a dentise or physician

    children under 6 years

    Instruct in good brushing and rinsing habits (to minimize swallowing)

    children under 2 years

    Ask a dentist or physician


  • Inactive Ingredients

    Water, Silica, Sorbital, Glycerin, PEG-8, Sodium Lauryl Sulfate, Disodium C12-14 Pareth-2 Sulfosuccinate,Flavor, Xanthan Gum,,PEG-60 Hydrogenated Castor Oil, Titanium Dioxide, Cellulose Gum, Sodium Fluoride,Sodium Saccharin, Algin, Stevia Rebaudiana Extract, O-Cymen-5-Ol


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

    Keep out of reach of children under 6 years of age
  • INGREDIENTS AND APPEARANCE
    ORA 2 STAIN CLEAR 
    sodium fluoride paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53050-001
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) SODIUM FLUORIDE 0.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Sorbitol (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    DISODIUM C12-14 SEC-PARETH-12 SULFOSUCCINATE (UNII: 10Y54T6DXH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    SODIUM SARCOSINATE (UNII: 6EHN3PQL8Z)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53050-001-01 25 g in 1 TUBE
    2 NDC:53050-001-02 40 g in 1 TUBE
    3 NDC:53050-001-03 5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 08/22/2012
    Labeler - Sunstar Guangzhou Ltd. (544725724)
    Establishment
    Name Address ID/FEI Business Operations
    Sunstar Guangzhou Ltd. 544725724 manufacture(53050-001)