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Acclean 60 Second Fluoride Treatment

Generic Name: sodium fluoride
Dosage Form: gel

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.

Directions

Storage

Store at room temperature

Warning

Caution: Store at room temperature.

Do not expose to excessive heat over 40°C, 104°F.

Keep out of reach of children.

Rx Only

Description

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.

Non-Medicinal

Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, red 33, saccharin sodium (anhydrous), titanium dioxide, bubble gum flavour.

Information in French and Barcode

Main Panel

ACCLEAN  60 SECOND FLUORIDE TREATMENT
fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0404-3963
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g  in 1 mL
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0404-3963-03 12 BOTTLE, PLASTIC in 1 CASE
1 NDC:0404-3963-01 480 mL in 1 BOTTLE, PLASTIC
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: 03/2017
 
Henry Schein Inc.



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