Special Packaging Flashcards
Aspirin
Aspirin containing preparations for human use for oral use are required to be in child resistant
packaging
– But there are the exceptions that we covered in the previous slides
Methyl Salicylate – liquid preparations that are more than 5% by weight
Sodium hydroxide and potassium hydroxide – 10% or more by weight if dry form, 2% or more by
weight if other
Turpentine - Household substances in liquid form containing 10 percent or more by weight of
turpentine
Methyl alcohol (methanol). Household substances in liquid form containing 4 percent or more by weight of methyl alcohol
Sulfuric acid - Household substances containing 10 percent or more by weight of sulfuric acid, except
such substances in wet-cell storage batteries
Prescription drugs - Any drug for human use that is in a dosage form intended for oral administration
and that is required by Federal law to be dispensed only by or upon an oral or written prescription of
a practitioner licensed by law to administer such drug shall be packaged in child resistant packaging
except for the exceptions on the upcoming pink slides
Ethylene glycol - Household substances in liquid form containing 10 percent or more by weight of ethylene glycol
Iron-containing drugs shall be in child resistant packaging, except
– Animal feeds used as vehicles for the administration of drugs, and
– Preparations in which iron is present solely as a colorant, noninjectable animal and human drugs
providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental
iron, from any source, in a single package, equivalent to 250 mg or more elemental iron in a
concentration of 0.025 percent or more on a weight to volume basis for liquids and 0.025 percent or
more on a weight to volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for
nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous products, such as pastes
and ointments, etc.)
Dietary supplements containing iron - Dietary supplements that contain an equivalent of 250
mg or more of elemental iron, from any source, in a single package in concentrations of 0.025
percent or more on a weight-to-volume basis for liquids and 0.05 percent or more on a weightto-
weight basis for nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous
products, such as pastes and ointments, etc.) shall be packaged in child resistant packaging
with the following exceptions:
* (i) Preparations in which iron is present solely as a colorant; and (ii) Powdered preparations with
no more than the equivalent of 0.12 percent weight-to-weight elemental iron.