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OraBrite (Oraline, Inc.)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 78 g in 1 TUBE (54371-471-03) Label Information
PASTE, DENTIFRICE 24 g in 1 TUBE (54371-471-01) Label Information
PASTE, DENTIFRICE 43 g in 1 TUBE (54371-471-02) Label Information

Complete OraBrite Information

  • Active Ingredient

    DRUG FACTS

    ACTIVE INGREDIENT:

    Sodium Fluoride 0.22%

    (Total Fluoride Content - 1000 ppm approx.)


  • Purpose

    PURPOSE: Anticavity Toothpaste.


  • Keep Out Of Reach Of Children

    WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


  • Use

    USE: Helps protect against cavities.


  • Warnings

    WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


  • Directions

    DIRECTIONS:

    Adults and children 2 tears 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 god brushing and rinsing habits. (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.


  • Inactive Ingredients

    INACTIVE INGREDIENTS:

    Hydrated Silica, Sorbitol, Deionized Water, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Lauryl Sulfate, Sodium Carboxymethylcellulose, Flavor, Sodium Saccharin.


  • Package Label

    Distributed by Oraline Inc., 823 NYS RT 13, Cortland, N.Y. 13045

    OraBrite

    Mint Flavor with Fluoride

    NET WT 1.50 oz.

    Mfg. Date and Batch No. on crimp.

    Product of China, produced for Oraline. 888-296-6730.  www.oraline.net

    Oraline OraBrite 2 Label



  • INGREDIENTS AND APPEARANCE
    ORABRITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54371-471
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54371-471-01 24 g in 1 TUBE
    2 NDC:54371-471-02 43 g in 1 TUBE
    3 NDC:54371-471-03 78 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 10/31/2011
    Labeler - Oraline, Inc. (179259361)
    Registrant - Oraline, Inc. (179259361)
    Establishment
    Name Address ID/FEI Business Operations
    Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. 527127383 manufacture(54371-471)