Phocal Apf

Manufacturer
U.S.I.A. Inc
Effective date
2013-02-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:16:37

Label at a glance#

ProductPhocal Apf
Active ingredientSodium Fluoride, HYDROFLUORIC ACID
Label structure8 sections

Dosage and administration

There are different methods for the placement of Phocal fluoride disks. The choice of placement method and Phocal type is subject to the discretion of the dental professional and is usually dependent upon the nature of the site being treated, interproximal tightness and the strength and type of adjacent restorations and teeth. Prior to treatment using either of the placement methods below, all debris and calculus ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

easy interproximal therapy

INSTRUCTIONS FOR USE

SPL UNCLASSIFIED SECTION

Purpose and Indications

INDICATIONS & USAGE SECTION

  • Phocal disks are topical delivery vehicles designed to fluoridate interproximal tooth surfaces. This action aids in the prevention of dental caries on intact surfaces, arrests progress on surfaces with incipient carious lesions and enhances remineralization. Phocal disks are also effective at tooth restoration margins and furcations.
  • Phocal disks are to be applied only by dental professionals at selected sites to achieve the desired benefits.

Description

DESCRIPTION SECTION

  • The patented Phocal topical fluoride disks are provided in two forms:
    • pink acidulated phosphate fluoride Apf disks
    • yellow non-acidic sodium fluoride pHn disks
  • These thin, round disks contain 1.23% fluoride ions. Once positioned interproximally they rapidly expand, soften into a gel and release fluoride for approximately 10 minutes before biodegrading. This release period can be increased as explained in the Directions for Use.
  • Each Phocal Apf disk contains 0.103mg of sodium fluoride and 0.009mg of hydrogen fluoride in a matrix of FD&C red 3, gum arabic, gelatin (of marine origin), propolis wax, phosphoric acid, sodium benzoate and water. These disks induce an optimized low pH environment that cleans and etches tooth surfaces and facilitates fluoride penetration and stimulates remineralization.
  • Each Phocal pHn disk contains 0.122mg of sodium fluoride in a matrix of gum arabic, gelatin (of marine origin), propolis wax, sodium benzoate and water. These disks are less acidic than the Phocal Apf disks and will not etch ceramic crowns or tooth-colored restorations while inducing fluoridation and remineralization.

Directions for Use

DOSAGE & ADMINISTRATION SECTION

  • There are different methods for the placement of Phocal fluoride disks.
  • The choice of placement method and Phocal type is subject to the discretion of the dental professional and is usually dependent upon the nature of the site being treated, interproximal tightness and the strength and type of adjacent restorations and teeth.
  • Prior to treatment using either of the placement methods below, all debris and calculus should be removed from the selected site(s) and the site(s) should remain dry during placement. Premature wetting softens the disks and can compromise correct interproximal placement.

Method 1 – Insertion of flat Phocal disks

SPL UNCLASSIFIED SECTION

Recommended for anterior teeth and where spacing allows.

  • When spacing allows, insert the flat Phocal disk interproximally with forceps and/or by hand directly between the contact points of the two adjacent teeth.
  • In some cases, separation with wedges may be necessary prior to insertion.FigureFigure

Method 2 – Insertion of folded Phocal disks

SPL UNCLASSIFIED SECTION

Recommended for posterior teeth and where spacing is restrictive.

  • Where spacing is restricted, or where the apical regions such as tooth restoration margins must be reached, the disk can be folded into a V shape and easily inserted below the contact point.
  • To fold the Phocal disk, lightly dampen the tips of a pair of thin forceps and shake off excess water, while keeping your hands completely dry. Use the tip of the thin forceps to moisten only the midline of the disk by moving the forceps tip back and forth along the midline. Be sure that midline is damp enough so the disk can fold without snapping.
  • Then hold the disk at the midline with the thin forceps and gently fold the disk into a V shape with dry fingers. If you feel that the disk could snap, stop folding and repeat the midline moistening step.
  • Insert the folded Phocal disk by hand and/or with forceps interproximally, with the apex at or below the contact area but over the gingival papillae and with each folded flap in contact with the wall of the adjacent teeth.
  • The folded Phocal disk apex can be pushed further into the contact area. To accomplish this, insert a thin probe under the fold of the disk to apply coronal pressure alone, or simultaneously with an apical wedge force from the interproximal occlusal surface.FigureFigure
  • In rare cases nickel titanium springs, elastic O-rings or Maxian strips can be used to separate teeth but this is usually a slower process which requires two visits: one for separation and then one for disk placement.
  • To accelerate the initial reactions of Phocal disks a curing light can be applied for 3-10 seconds.
  • To extend the fluoride release time period, a varnish can be applied to partially cover the interproximal site or disk occlusally, buccally or/and lingually. However the disk should not be completely coated with varnish.
  • To shorten the release time the disks can be removed using an appropriate instrument, dental floss and/or aspiration.
  • If Phocal Apf is used, in order to guard against possible etching of porcelain crowns or tooth-colored restorations, a protective matrix should be used. With Phocal pHn there is no risk of etching.
  • Advise the patient not to eat, drink or rinse for at least 30 minutes after treatment.
  • If multiple applications are necessary, treat no more than 8 sites at a time and delay subsequent Phocal applications for at least a day.
  • If deemed necessary, patients may be recalled at intervals of 2 to 12 months for repeated treatments.
  • Phocal disks are versatile, and with specific gentle moisturization they can be trimmed, rolled, or folded to fit other inaccessible areas such as furcations.

Warnings

WARNINGS SECTION

  • In rare cases, sensitivity or adverse reactions may be experienced. In such cases immediately remove the disks while preventing swallowing and refer the patient to a physician.
  • Patients less than 12 years old and patients with special needs should remain under professional supervision until the Phocal disks have biodegraded or have been removed.
  • The disks are not intended for systemic ingestion and should be kept out of children's reach. If more than 20 disks are accidently swallowed, seek immediate medical assistance.
  • Phocal should not be applied in sites with: gingival inflammation, immediately prior to or after oral soft tissue surgery and in cases of known allergies to any of the Phocal ingredients.
  • Phocal is to be sold as unbroken boxes with all disks sealed within the blister packs and is to be used for application in the dental office by professionals only.
  • When Phocal treatment is utilized, routine systemic and topical administrations of fluoride should be suspended during the day of application.
  • Since the propolis wax and gelatin used in Phocal disks are natural products, they may occasionally interact to produce brownish spots or discoloration. This does not indicate that there is any hazard or danger in using the product.
  • Recommended storage temperatures are 40°F-75°F (5°C-25°C).

Responsibility of the Professional

SPL UNCLASSIFIED SECTION

  • Phocal disks have been developed for use only by licensed professionals in the dental care setting. Colldent Ltd warrants the quality of the products for the uses described and when used in the manners outlined here and in our sales and delivery documents. It is the responsibility of the professional to use the products in such manner.

For additional information
www.Phocaltherapy.com • 888-Phocal-3 (746-2253)

QUICK REFERENCE INSERTION GUIDE

SPL UNCLASSIFIED SECTION

The interproximal sites and disk must be kept dry during placement.

Method 1 – Insertion of flat Phocal disks

Recommended for anterior teeth and where spacing allows

Figure
Figure

When spacing allows, insert the disk with forceps and/or by hand.

Figure
Figure

In some cases, separation with wedges may be necessary prior to insertion.

Method 2 – Insertion of folded Phocal disks

Recommended for posterior teeth and where spacing is restrictive

When spacing is restrictive, the disk can be folded and easily inserted below the contact point.

Figure
Figure

To fold, lightly dampen the tips of a pair of thin forceps and shake off excess water, while keeping your hands completely dry.

Use the tip of the thin forceps to moisten only the midline of the disk by moving the forceps tip back and forth along the midline. Then hold the disk along the midline with the thin forceps and gently fold the disk into a V shape with dry fingers.

If you feel that the disk could snap, stop folding and repeat the midline moistening step.

Figure
Figure

Insert the folded disk below the contact area as shown.

Use a thin probe to push the disk further into the contact area.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display panel – Box Label

fluoride treatment disks
for professional use only

phocal™ Apf

easy interproximal therapy

20 disks,
4.5mg each

phocal

Apf disks

Principal Display panel – Box Label
Principal Display panel – Box Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55918-001-202019-11-27C16284748780-19855d018-e465-cd31-e053-dbdaa90ab51aphocal™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55918-001-20Phocal Apf2 in 1 BOXDISC21
55918-001-20Phocal Apf10 in 1 BLISTER PACKDISC101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55918-001PHOCAL APF (SODIUM FLUORIDE, HYDROFLUORIC ACID) DISC [U.S.I.A. INC]1Legacy NDC, 2 package rows20130305_a38c8eab-7763-48ec-8e6b-8199022be081.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
ACACIAINACTIVE INGREDIENT5C5403N26O1
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQY1
gelatinINACTIVE INGREDIENT2G86QN327L1
phosphoric acidINACTIVE INGREDIENTE4GA8884NN1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55918-00155918-001-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRAVENOUS1294 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / SUBLINGUAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNLOTION / TOPICAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNCREAM / TOPICAL13 mgExact identifier — unii candidate
28 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNTABLET, ORALLY DISINTEGRATING / ORAL4 mgExact identifier — unii candidate
28 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
gelatinGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNTABLET, EXTENDED RELEASE / ORAL0.19 mgExact identifier — unii candidate
28 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
gelatinGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNSOLUTION / TOPICAL0.23 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
gelatinGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
gelatinGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNOINTMENT / TOPICALADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUFILM / BUCCAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
gelatinGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
gelatinGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
gelatinGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNCREAM / VAGINAL0.56 %w/wExact identifier — unii candidate
28 equally ranked IID candidates
gelatinGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNTABLET, FILM COATED, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates

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
ac036ab4-3bae-41ac-a96a-ee269149ac19a38c8eab-7763-48ec-8e6b-8199022be0812013-02-12WarningsExact identifier
spl id: ac036ab4-3bae-41ac-a96a-ee269149ac19
spl set id: a38c8eab-7763-48ec-8e6b-8199022be081

Reported adverse events (FAERS/openFDA)#

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