Label: ORABRITE- sodium fluoride paste, dentifrice

  • 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 November 14, 2012

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54371-471
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54371-471-0124 g in 1 TUBE
    2NDC:54371-471-0243 g in 1 TUBE
    3NDC:54371-471-0378 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/31/2011
    Labeler - Oraline, Inc. (179259361)
    Registrant - Oraline, Inc. (179259361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.527127383manufacture(54371-471)
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