SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE- sodium fluoride paste

Smile Active Pro Tartar Control Fluoride by

Drug Labeling and Warnings

Smile Active Pro Tartar Control Fluoride by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SMILE ACTIVE PRO TARTAR CONTROL FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-039
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-039-22	57 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2023
2	NDC: 70605-039-96	170 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	04/01/2023

Labeler - Guthy-Renker LLC (948861877)