ACCLEAN 60 SECOND FLUORIDE TREATMENT- fluoride gel

Acclean by

Drug Labeling and Warnings

Acclean by is a Prescription medication manufactured, distributed, or labeled by Henry Schein Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

INGREDIENTS AND APPEARANCE

ACCLEAN  60 SECOND FLUORIDE TREATMENT
fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-9405
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	purple	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-9405-03	12 in 1 CASE	03/03/2017
1	NDC: 0404-9405-01	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)