Label: AURAGLOW DAILY- 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

    Deionized water, sorbitol, hydrated silica, xylitol,

    glycerin, polyethylene glycol, sodium methyl

    cocoyl taurate, flavor, cellulose gum, dimethicone,

    monosodium phosphate, stevia, sodium benzoate

  • Package Labeling

    ​Auraglow

    Daily

    Toothpaste

    Strengthens Teeth

    and prevents cavities.

    _____________________

    Wintergreen

    C​ONTAINS FLUORIDE

    _____________________

    NET WT 4.0 OZ (113G)

    Distr. by Auraglow LLC, Stamford, CT 06901

    002 Crtn

    002 Btl

    res

  • INGREDIENTS AND APPEARANCE
    AURAGLOW DAILY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81740-002
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81740-002-011 in 1 CARTON08/01/2021
    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 finalpart35508/01/2021
    Labeler - Auraglow LLC (066094893)
    Registrant - Auraglow LLC (066094893)
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