Label: AURAGLOW WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.243%

    (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose  Anticavity

  • INDICATIONS & USAGE

    Use  Aids in prevention of dental cavities.

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    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 right away.

  • DOSAGE & ADMINISTRATION

    Directions 

    • Adults and children 2 years of age and
    older: Brush teeth thouroughly, 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 good 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 INGREDIENT

    Inactive Ingredients

    Sorbitol, hydrated silica, deionized water,

    glycerin, hydrogen peroxide, polyethylene

    glycol, sodium tripolyphosphate, cellulose

    gum, sodium methyl cocoyl tautate,

    flavor, stevia, sodium bicarbonate

  • Package Labeling

    ​Auraglow

    Whitening Toothpaste

    Wintergreen

    C​ONTAINS FLUORIDE &

    3% HYDROGEN PEROXIDE

    NET WT 4.0 OZ (113G)

    Distr. by Auraglow LLC, Stamford, CT 06901

    001 Crtn

    001 Tube

    res

  • INGREDIENTS AND APPEARANCE
    AURAGLOW WHITENING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81740-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81740-001-011 in 1 CARTON07/01/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/01/2021
    Labeler - Auraglow LLC (066094893)
    Registrant - Auraglow LLC (066094893)
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