ACCLEAN DUAL FLUORIDE RINSE PART B 1.24% MINT- fluoride liquid

Acclean by

Drug Labeling and Warnings

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

Drug Details [pdf]

Description

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

Directions

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

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

Warning: 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

INGREDIENTS AND APPEARANCE

ACCLEAN  DUAL FLUORIDE RINSE PART B 1.24% MINT
fluoride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0404-9034
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02522 g  in 1 mL

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-9034-03	3 in 1 CASE	03/03/2017
1	NDC: 0404-9034-01	1890 mL in 1 BOTTLE, PUMP; 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 (012430880)