Labeling must bear directions for each recommended use. The directions
for use must include, but are not limited to*,
the following:
1. The major areas in which the product is recommended for use (e.g.
restaurants, dairies, food processing plants).
2. The identification of the types of hard surfaces, or objects, intended
for treatment.
3. The necessity for removal of gross food particles and soil by a
pre-flush, or pre-scrape and, when necessary, pre-soak treatment. In
addition, instructions must be provided for thoroughly washing the surfaces
or objects with a good detergent or compatible cleaner, followed by
a potable water rinse prior to application of the sanitizing solution.
4. The recommended use dilution and instructions for preparing it.
The units of measure (e.g. tablespoons, ounces, quarts, gallons) to
be employed in diluting the product must be given, and must be understandable
to the user. The concentration (ppm) of principal active ingredient
(e.g. titratable iodine, available chlorine, active quaternary) provided
by the recommended use solution should also be given.
5. The method of application (e.g. immersion, flooding, spraying)
to wet all surfaces thoroughly. Additional instructions for in-place
sanitizing may be required (e.g. filling piping with the sanitizing
solution).
6. The contact time of at least 1 minute required for sanitization.
The directions must also indicate if, and how, the product is to be
removed from the surfaces after the recommended contact time. Instructions
to drain the use solution from the surface and air dry are appropriate
for product cleared for use on food contact surfaces under the Federal
Food, Drug and Cosmetic Act. A potable water rinse must be recommended
for removal of the use solution from the food contact surface under
any other circumstances.
7. For mechanical operations, the limitation that the prepared use
solution may not be re-used for sanitizing but may be re-used for other
purposes such as cleaning. For manual operations, the recommendation
that fresh sanitizing solution should be prepared at least daily or
more often if the solution becomes diluted or soiled.
