Label: MADE BY DENTISTS, INC. EYEBALL JUICE- sodium fluoride paste

  • NDC Code(s): 75065-022-06
  • Packager: Made By Dentists, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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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:
    Glycerin, Water (Aqua), Hydrated Silica, Sorbitol,
    Xylitol, Flavor, Cocamidopropyl Betaine, Xanthan
    Gum, Stevia Rebaudiana Leaf Extract, Citric Acid,
    Ipomoea Batatas Root Extract

  • QUESTIONS

    Questions?  +1 (646) 980-6461

  • EyeBall Toothpaste Product Labeling

    EyeBall Toothpaste

    Made By Dentists ​™

    FOR KIDS

    NET WT 4.2 Oz / 120g

    MADE IN THE USA

    @Copyright: 2022 Made By Dentists

    439 S. Cedros Avenue, Suite 402.

    Solana Beach, CA, 92075

    Carton

    Eyeball Juice Box

    Tube

    Eyeball Juice Tube

    res

  • INGREDIENTS AND APPEARANCE
    MADE BY DENTISTS, INC. EYEBALL JUICE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-022
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SWEET POTATO (UNII: M9WGG9Z9GK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75065-022-061 in 1 CARTON01/24/2023
    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 DrugM02101/24/2023
    Labeler - Made By Dentists, Inc. (117405870)
    Registrant - Made By Dentists, Inc. (117405870)
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