Acclean Foam Fluoride 60 Second Application Aerosol, Foam
FDA Label NDC 0404-1721

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein for the product Acclean Foam Fluoride 60 Second Application (NDC 0404-1721). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding general information, indications, warnings, instructions for use, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ General Information

→ Indications

→ Warnings

→ Instructions For Use

→ Principal Display Panel

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.

Indications

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

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.

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

0404-1701-44 (0404 1701 44)

0404-1711-44 (0404 1711 44)

0404-1721-44 (0404 1721 44)

0404-1731-44 (0404 1731 44)

0404-1741-44 (0404 1741 44)

* Please review the disclaimer below.

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