Acclean

Manufacturer
Henry Schein
Effective date
2020-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:02:42

Label at a glance#

ProductAcclean Dual Fluoride Rinse 1.24% APF Bubblegum
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Storage and handling

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

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

A water soluble topical fluoride rinse to assist in preventing dental caries. For professional use only.

Direction

DOSAGE & ADMINISTRATION SECTION

Directions:

Read directions carefully before using. The following treatment method provides a high initial protection level on tooth surfaces.

Adults and children 6 years of age and older: use as indicated below, inconjunction with oral hygiene program.

1.For combined Stannous fluoride and A.P.F treatment, dispense 7 mL of Acclean Stannous fluoride concentrate (part A) and 7 mL of Acclean A.P.F. (part B) into a cup by depressing each plunger once.

2.Add 21 mL of water and mix well. This provides a 0.33% Stannous solution with 0.25% acidulated phosphate fluoride.

3.Instruct patient to rinse mouth with 1/2 of the solution for 60 seconds.

4.Expectorate and repeat the procedure with the remaining solution.

5.Use only freshly prepared solution for each patient.

6.Instruct patient not to eat or drink for 30 minutes after use.

Warning

WARNINGS AND PRECAUTIONS SECTION

Children under 12 years of age should be supervised during treatment.

Consult a dentist or doctor before using on children under 6 years of age.

Keep out of reach of children under age 6.

Do not swallow.

Rx Only

Storage

STORAGE AND HANDLING SECTION

Warnings: 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.02

Main Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

104-9035 Full Panel104-9035 Full Panel

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-90350404-9035-01, 0404-9035-03

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 · Source PDF

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
b60dcbd1-42d3-646f-e053-2a95a90a497d49cb2a07-2b8d-4709-e054-00144ff88e882020-12-09WarningsExact identifier
spl id: b60dcbd1-42d3-646f-e053-2a95a90a497d
spl set id: 49cb2a07-2b8d-4709-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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