104-6311 Mint Henry Schein Acclean 60 Second Fluoride Treatment Gel 1.23% APF

Manufacturer
Henry Schein Inc.
Effective date
2018-12-29
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:38:08

Label at a glance#

ProductAcclean 60 Second Fluoride Treatment
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Dosage and administration

Directions: 1.Shake well before using 2.Use after thorough prophylaxis 3.To dispense, fill tray(s) 1/3 with gel 4.Dry teeth completely. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds or up to four minutes for optimal uptake 5.Advise patient not to eat, drink or rinse for 30 minutes after the treatment

Storage and handling

Cautions: Store at room temperature. Do not expose to excessive heat over 40°C, 104°F.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

Henry Schein 104-6311 Mint Gel

Acclean 60 Second Fluoride Treatment

1.23% APF

16.2 fl oz (480 mL)

NDC 0404-5676-01

A topical anticaries preparation for professional use only.

1.23% fluoride ion from sodium fluoride. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavored.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

1.Shake well before using
2.Use after thorough prophylaxis
3.To dispense, fill tray(s) 1/3 with gel
4.Dry teeth completely. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds or up to four minutes for optimal uptake
5.Advise patient not to eat, drink or rinse for 30 minutes after the treatment

Non-Medicinal

INACTIVE INGREDIENT SECTION

Non-Medicinal ingredients: Carboxy methyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, yellow dye, blue dye, peppermint oil, spearmint oil

Warning

WARNINGS AND PRECAUTIONS SECTION

Cautions: Keep out of reach of children.

RX only

Storage

STORAGE AND HANDLING SECTION

Cautions: Store at room temperature. Do not expose to excessive heat over 40°C, 104°F.

SPL UNCLASSIFIED SECTION

Distributed by (in US only): Henry Schein Inc., 135 Duryea Road, Melville, NY 11747 USA

Made in USA

Rev.03

Main Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panel 1Panel 1Panel 2Panel 2Panel 3Panel 3

Products#

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DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-56760404-5676-01, 0404-5676-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
b60db699-077e-17ef-e053-2995a90a60c74967cd4a-3762-4e18-e054-00144ff8d46c2020-12-09WarningsExact identifier
spl set id: 4967cd4a-3762-4e18-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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