Scotts Select Neutral APF Fluoride

SCOTTS SELECT NEUTRAL APF FLUORIDE- sodium fluoride gel
Scott’s Dental Supply LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Facts

Active Ingredient	Purpose
Sodium Fluoride 2%	Anticaries

Use

Prescription fluoride treatment gel used to prevent dental decay.

Warnings

• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center immediately.
• Do not use on patients with an allergy to fluoride.
• Scott’s APF Gel contains artificial color, confirm that no known patient allergies exist.
• For professional use only.

Directions

• Shake well before use.
• This is a four minute fluoride gel for in-office patient use.
• For best results, use at least twice a year.
• After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
• Instruct patient to bite down lightly but firmly for four minutes.
• Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information

• Store at 59° –86°F (15°–30°C).
• Protect from freezing.
• Scott’s APF Gel is free of gluten, soy, milk, egg, peanut and tree nut products.

Inactive Ingredients

Citric Acid, FD&C Green No. 3 (C.I. 42053), FD&C Yellow No. 5 (C.I. 19140), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol.

With Xylitol & Vitamin E

Neutral PH Phosphate Fluoride Treatment Gel 2% Sodium Fluoride

Mfg for
Scott’s
Dental Supply^®
Fife, WA 98424
1-800-901-3368
www.SCOTTSDENTAL.com

Rx ONLY
USA
Rev. A Date: 02/25/2020

PRINCIPAL DISPLAY PANEL — 500 mL Bottle Label

NDC 69638-157-16

Scott’s
✓SELECT

NEUTRAL APF GEL
Thixotropic
4 minute treatment

MINT
17 fl. oz. (500mL)

REORDER 245-2006

GLUTEN FREE
SCOTT’S SELECT

SATISFACTION
Quality
GUARANTEED

SCOTTS SELECT NEUTRAL APF FLUORIDE sodium fluoride gel

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69638-157 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.02 g in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID HYDROFLUORIC ACID MAGNESIUM ALUMINUM SILICATE PHOSPHORIC ACID POLYSORBATE 20 POTASSIUM HYDROXIDE WATER SODIUM BENZOATE SACCHARIN SODIUM TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- XANTHAN GUM XYLITOL FD&C GREEN NO. 3 FD&C YELLOW NO. 5

Product Characteristics Color GREEN Score Shape Size Flavor MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69638-157-16 500 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2013

Labeler — Scott’s Dental Supply LLC (137217043)

Revised: 03/2020 Scott’s Dental Supply LLC