ACCLEAN DUAL FLUORIDE RINSE 1.24% APF BUBBLEGUM- fluoride liquid 
Henry Schein

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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104-9035 Bubble Gum
Henry Schein Acclean Dual Fluoride Rinse Part B
1.24% APF

Description

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

Direction

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

Warnings: 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.02

Main Panel

104-9035 Full Panel

ACCLEAN  DUAL FLUORIDE RINSE 1.24% APF BUBBLEGUM
fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-9035
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02522 g  in 1 mL
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-9035-033 in 1 CASE03/03/201712/31/2020
1NDC:0404-9035-011890 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/03/201712/31/2020
Labeler - Henry Schein (012430880)

Revised: 12/2020
 
Henry Schein