ACCLEAN 60 SECOND FLUORIDE TREATMENT- fluoride gel 
Henry Schein Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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104-6401 Grape
Henry Schein Acclean 60 Second Fluoride Treatment Gel
1.23% APF

Description

Henry Schein 104-6401 Grape Gel

Acclean 60 Second Fluoride Treatment

1.23% APF

16.2 fl oz (480 mL)

NDC 0404-9405-01

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

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

Non-Medicinal ingredients: Carboxy methyl cellulose sodium, phosphoric acid, water, red dye, blue dye, saccharin sodium, titanium dioxide, grape flavour

Warning

Cautions: Keep out of reach of children.

RX only

Storage

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

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

Made in USA

Rev.03

Main Panel

104-6401 Panel 01104-6401 Panel 02104-6401 Panel 03

ACCLEAN  60 SECOND FLUORIDE TREATMENT
fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-9405
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-9405-0312 in 1 CASE03/03/201711/30/2020
1NDC:0404-9405-01480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/03/201711/30/2020
Labeler - Henry Schein Inc. (012430880)

Revised: 12/2020
Document Id: b60dbd9d-2cbf-5968-e053-2a95a90ac898
Set id: 4967da0b-eb45-279b-e054-00144ff8d46c
Version: 3
Effective Time: 20201209
 
Henry Schein Inc.