SCOTTS SELECT NEUTRAL APF FLUORIDE- sodium fluoride gel

Scotts Select Neutral APF Fluoride by

Drug Labeling and Warnings

Scotts Select Neutral APF Fluoride by is a Prescription medication manufactured, distributed, or labeled by Scott's Dental Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

DESCRIPTION

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.

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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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69638-157-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2013

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)