Notarika, S.A. de C.V.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA laboratory testing of a batch of this product detained at the border found that your Greenfrog HAND SANITIZER contained an average of 0% ethanol and 54%

Passage 2

the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 3

Greenfrog HAND SANITIZER, a drug product labeled as manufactured by your facility, is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol ethyl alcohol (ethanol).

Passage 4

The failure of this product to list methyl alcohol (methanol) as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C.

Passage 5

Greenfrog HAND SANITIZER is not labeled in accordance with the “Drug Facts” labeling requirements described in 21 CFR 201.66.

Passage 6

Therefore, this product is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under

Passage 7

Greenfrog HAND SANITIZER is misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product label does not include all of the applicable warnings as required under 21 CFR 330.1(g). Specifically, the label does not include the warning statement required for drugs used topically that reads “If swallowed, get medical help or contact a Poison Control Center right away.”

Passage 8

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because Greenfrog HAND SANITIZER is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C.

Passage 9

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this hand sanitizer product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your Greenfrog HAND SANITIZER drug product is GRASE for

Passage 10

An inactive ingredient used in OTC monograph drugs must meet the requirements of 21 CFR 330.1(e), which requires, among other things, that inactive ingredients must be safe in the amount administered.