Other
This is a hand sanitizer manufactured according to 21 CFR part 210, 211, 333, and 330*.* In Health Care Antiseptic Final Rule: Finalizes rulemaking for healthcare antiseptics, a final monograph determination was not made for three active ingredients: Isopropyl alcohol 70-91.3 percent, Benzalkonium chloride, and Alcohol (ethyl alcohol) 60 to 95 percent. These active ingredients were classified as Category III.
Therefore, according to 21 USC 355h, this hand sanitizer is not required to be the subject of an application approved under section 355 of Title 21 because this hand sanitizer is:
(i) classified in category III for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part 330 of title 21, Code of Federal Regulations;
(ii) in conformity with-
(I) the conditions of use, including indication and dosage strength, if any, described for the Health care personnel hand rub with the active ingredient Alcohol 60 to 95 percent in such preamble or in an applicable subsequent proposed rule;
(II) the proposed requirements for drugs classified in such tentative final monograph in category I in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug; and
(III) the general requirements for nonprescription drugs and conditions or requirements under subsection (b) or (k) of 21 USC 355h; and
(iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under section 321(p)(2) of Title 21.
The hand sanitizer is formulated using only the following ingredients:
Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (71%, volume/volume (v/v)) in an aqueous solution denatured with Isopropanol according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Aloe Vera Leaf.
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)
Sterile distilled water or boiled cold water.
