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.

----------

104-7923 Strawberry
Henry Schein Acclean 60 Second Fluoride Treatment Gel
1.23% APF

Description

Henry Schein 104-7923 Strawberry Gel

Acclean 60 Second Fluoride Treatment

1.23% APF

16.2 fl oz (480 mL)

NDC 0404-3339-01

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, saccharin sodium, titanium dioxide, strawberry flavor.

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

Panel 1Panel 2Panel 3

ACCLEAN  60 SECOND FLUORIDE TREATMENT
fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-3339
Route of Administration DENTAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.0272 g  in 1 mL
Product Characteristics
Color pink Score     
Shape Size
Flavor STRAWBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0404-3339-03 12 in 1 CASE 03/03/2017
1 NDC:0404-3339-01 480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/03/2017
Labeler - Henry Schein Inc. (012430880)

Revised: 12/2018
Document Id: 7de41cb1-0e7b-ce87-e053-2a91aa0a0817
Set id: 4967da0b-eb47-279b-e054-00144ff8d46c
Version: 2
Effective Time: 20181225
 
Henry Schein Inc.