SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE- sodium fluoride paste 
Guthy-Renker LLC

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.

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Smile Active Pro Tartar Control Fluoride Toothpaste

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

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

Other information

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

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
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)

Revised: 11/2022
Document Id: aac5f0d6-c243-4487-884e-d66695758988
Set id: 9a9344cb-1218-47f6-b541-f48fffca754a
Version: 2
Effective Time: 20221123
 
Guthy-Renker LLC