Acclean

Acclean
SPL v3
SPL
SPL Set ID c10af938-0537-2425-e053-2a95a90ad608
Route
DENTAL
Published
Effective Date 2023-10-03
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0272 g)
Inactive Ingredients
Sodium Phosphate, Monobasic, Anhydrous Betaine Xylitol Poloxamer 407 Sucralose

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-04-28 Until 2023-03-31
Description

Henry Schein, Inc. Acclean Foam Fluoride 60 Second Application Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion) Contains: Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant. Gluten free.

Medication Information

Description

Henry Schein, Inc. Acclean Foam Fluoride 60 Second Application Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion) Contains: Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant. Gluten free.

Warnings

Contens under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 50-80F. Keep from freezing. do not spray toward open flame.

Indications

For topical application to aid in the protection against dental caries.

General Information

Henry Schein, Inc.

Acclean Foam Fluoride 60 Second Application

Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion)

Contains:

Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant.

Gluten free.

Instructions for Use
  • Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense, invert can completely upside down. Slowly depress nozzle to fill fluoride applicator tray (foam will expand slightly higher than fluoride tray).
  • Tooth surface must be dry prior to inserting tray(s) in mouth.
  • Insert tray(s) into mouth and have patient bite down for 1-4 minutes.
  • Remove tray(s) and have patient expectorate.
  • Advise patient not to eat, drink or rinse for 30 minutes after treatment.

Professional Use Only

Principal Display Panel

Structured Label Content

Warnings

Contens under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 50-80F. Keep from freezing. do not spray toward open flame.

Indications

For topical application to aid in the protection against dental caries.

General Information

Henry Schein, Inc.

Acclean Foam Fluoride 60 Second Application

Acidulated Phosphate Fluoride Foam (1.23% Fluoride Ion)

Contains:

Sodium fluoride in a proprietary acidulated phophate flavored foam base. 1.23% fluoride ion is available from 2.72% sodium fluoride. Does not contain chlorofluorocarbon propellant.

Gluten free.

Instructions for Use (Instructions For Use)
  • Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense, invert can completely upside down. Slowly depress nozzle to fill fluoride applicator tray (foam will expand slightly higher than fluoride tray).
  • Tooth surface must be dry prior to inserting tray(s) in mouth.
  • Insert tray(s) into mouth and have patient bite down for 1-4 minutes.
  • Remove tray(s) and have patient expectorate.
  • Advise patient not to eat, drink or rinse for 30 minutes after treatment.

Professional Use Only

Principal Display Panel

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:39:02.139661 · Updated: 2026-03-14T21:56:26.485644