Label: SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE- sodium fluoride paste

  • NDC Code(s): 70605-039-22, 70605-039-96
  • Packager: Guthy-Renker LLC
  • 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 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.248% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    • Helps protect against cavities
  • Warnings

    Keep out of reach of children under 6 years of age. If more than for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age or older, brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    • To minimize swallowing, use a pea-sized amount for children under 6.
    • Supervise children's brushing until good habits are established.
    • Children under 2 years of age, ask a dentist or physician.
  • Other information

    • Twist off cap to remove foil seal.
    • Do not use if safety seal is missing or broken.
  • Inactive ingredients

    Sorbitol, Hydrated Silica, Water, Glycerin, Xylitol, Pentasodium Triphosphate, Cocamidopropyl Betaine, Titanium Dioxide, Flavor, Xanthan Gum, Sodium Methyl Cocoyl Taurate, Sucralose, Glycine, Sodium Ascorbyl Phosphate, Sodium Hyaluronate, Hydrolyzed Hyaluronic Acid.

  • Questions or comments?

    888-575-5700 www.smileactives.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: Oral Care Products, LLC
    El Segundo, CA 90245

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Label

    smileactives PRO™

    Tartar Control
    Fluoride Toothpaste

    Vanilla Mint

    For Healthy Gums
    (with Amino Acids & Hyaluronic Acid)

    6 OZ / 170 g

    PRINCIPAL DISPLAY PANEL - 170 g Tube Label
  • INGREDIENTS AND APPEARANCE
    SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-039
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium Tripolyphosphate Anhydrous (UNII: 9SW4PFD2FZ)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    Glycine (UNII: TE7660XO1C)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-039-2257 g in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    2NDC:70605-039-96170 g in 1 TUBE; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35504/01/2023
    Labeler - Guthy-Renker LLC (948861877)
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