Jabones Pardo S.A.

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.