Label: MADE BY DENTISTS WHITENING- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 22, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient: Sodium Fluoride 0.24%

  • PURPOSE

    Purpose:  Anticavity

  • INDICATIONS & USAGE

    Use: Aids in the prevention of 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 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 good
      brushing and rinsing habits (to minimize swall-
      owing), and only use a pea size amount.
    • 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:

  • QUESTIONS

    Questions or comments?

    +1 (646) 980-6461

  • Product Labeling

    Made By Dentists​™

    Whitening

    Toothpaste

    Fresh Mint Flavor

    Fluoride Anticavity Toothpaste

    NET WT 4.2 Oz / 120 g

    MADE IN THE USA

    90 South Dale, Suite 8, Saint Paul,

    Minnesota, USA 55102

    Carton

    Whitng 015 Crtn

    Tube

    Whitng 015 Tube

    res

  • INGREDIENTS AND APPEARANCE
    MADE BY DENTISTS WHITENING 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-015
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75065-015-061 in 1 CARTON07/15/2022
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/15/2022
    Labeler - Oral Spotlight Care Inc (117405870)
    Registrant - Oral Spotlight Care Inc (117405870)
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