FDA.reportPublic FDA data

Scotts Select APF Foam Fluoride

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

Label at a glance#

ProductScotts Select APF Foam Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds. To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray). Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes. ...

Storage and handling

Store at room temperature 59° –86°F (15°–30°C).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

DESCRIPTION SECTION

Active IngredientPurpose
1.23% Fluoride IonFluoride Treatment Foam

Use

INDICATIONS & USAGE SECTION

This is a prescription fluoride treatment foam used to help prevent dental decay.

Warnings

WARNINGS SECTION

  • Keep out of reach of children.
  • Do not swallow.
  • Contents under pressure.
  • Do not place in hot water or near radiators, stoves or other sources of heat.
  • Do not puncture or incinerate container. Do not spray toward open flame.
  • For professional use only.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
  • Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
  • Use a saliva ejector during treatment to minimize ingestion of product.
  • Remove tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 59° –86°F (15°–30°C).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caster Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharine, Triethanolamine, Xylitol.

SPL UNCLASSIFIED SECTION

MINT

Shake well before each use

INVERT CAN COMPLETELY AND DEPRESS NOZZLE TO DISPENSE

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Mfg for: Scott's Dental Supply
Fife, WA 98424
1-800-901-3368
WWW.SCOTTSDENTAL.COM

Rx Only
USA
Rev. A Date: 07/25/2016

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69638-068-04

Scott's
✓SELECT

APF FOAM
With Xylitol

Acidulated Phosphate
Fluoride Treatment Foam

1.23% Fluoride Ion

1 minute or 4
minute treatment

4.4 fl. oz. (130mL)

REORDER 245-2600

GLUTEN FREE
SCOTT'S SELECT

SATISFACTION
Quality
GUARANTEED

PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 130 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
831719sodium fluoride 1.23 % Oral FoamPSN1
831719sodium fluoride 12.3 MG/ML Oral FoamSCD1
831719sodium fluoride 1.23 % Oral FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69638-068-042022-01-28C16284748780-1d6a99b39-a1b8-a426-e053-dadaa90af4c2Scott's SELECT APF FOAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69638-068-04Scotts Select APF Foam Fluoride130 mL in 1 BOTTLEAEROSOL, FOAM1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69638-068SCOTTS SELECT APF FOAM FLUORIDE (SODIUM FLUORIDE) AEROSOL, FOAM [SCOTTS DENTAL SUPPLY LLC]1Legacy NDC, 1 package rows20200307_a71f92b6-7b0e-4f55-8342-23268dcd3799.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69638-06869638-068-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CASTOR OILD5340Y2I9GIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
WATER059QF0KO0RIACT
HYDROFLUORIC ACIDRGL5YE86CZIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XYLITOLVCQ006KQ1EIACT
POLOXAMER 407TUF2IVW3M2IACT
TROLAMINE9O3K93S3TKIACT

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
3ddf7b40-8d7b-48b2-8efc-13b8c599db76a71f92b6-7b0e-4f55-8342-23268dcd37992020-03-03WarningsExact identifier
spl id: 3ddf7b40-8d7b-48b2-8efc-13b8c599db76
spl set id: a71f92b6-7b0e-4f55-8342-23268dcd3799

Reported adverse events (FAERS/openFDA)#

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