Label: MADE BY DENTISTS, INC. ALIEN BLOOD- sodium fluoride paste

  • NDC Code(s): 75065-020-06
  • Packager: Made By Dentists, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 8, 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, Cocamidopropyl Betaine, Flavor, Xanthan
    Gum, Stevia Rebaudiana Leaf Extract, Capsicum
    Annum Extract, Raphanus Sativus, (Radish)
    Root Extract

  • QUESTIONS

    Questions?  +1 (646) 980-6461

  • Alien Blood Toothpaste Product Labeling

    Alien Blood 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

    Alien Blood Box

    Tube

    Alien Blood Tube

    res

  • INGREDIENTS AND APPEARANCE
    MADE BY DENTISTS, INC. ALIEN BLOOD 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-020
    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)  
    CAPSICUM (UNII: 00UK7646FG)  
    RAPHANUS SATIVUS (UNII: 86R5J6D01D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75065-020-061 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 finalpart35501/24/2023
    Labeler - Made By Dentists, Inc. (117405870)
    Registrant - Made By Dentists, Inc. (117405870)
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