FDA.reportPublic FDA data

Scott's SELECT NEUTRAL APF GEL

Manufacturer
Scott's Dental Supply LLC
Effective date
2020-03-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:32:45

Label at a glance#

ProductScotts Select Neutral APF Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

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 fo...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

DESCRIPTION SECTION

Active IngredientPurpose
Sodium Fluoride 2%Anticaries

Use

INDICATIONS & USAGE SECTION

Prescription fluoride treatment gel used to prevent dental decay.

Warnings

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245593sodium fluoride 2 % Dental GelPSN1
245593sodium fluoride 0.02 MG/MG Oral GelSCD1
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY1
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69638-157-162022-01-28C16284748780-1d6a99b39-a5b1-a426-e053-dadaa90af4c2Scott's SELECT NEUTRAL APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69638-157-16Scotts Select Neutral APF Fluoride500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69638-157SCOTTS SELECT NEUTRAL APF FLUORIDE (SODIUM FLUORIDE) GEL [SCOTT'S DENTAL SUPPLY LLC]1Legacy NDC, 1 package rows20200507_bfd92953-42ca-4e12-97bf-5d0aac69a4d8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69638-15769638-157-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HYDROFLUORIC ACIDRGL5YE86CZIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
FD&C GREEN NO. 33P3ONR6O1SIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e79ce76e-2024-464e-9321-60e8f4708035bfd92953-42ca-4e12-97bf-5d0aac69a4d82020-03-12WarningsExact identifier
spl id: e79ce76e-2024-464e-9321-60e8f4708035
spl set id: bfd92953-42ca-4e12-97bf-5d0aac69a4d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.