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IA #66-11 - REVISED 9/21/92, "Tatex Tattoo Remover"

TYPE OF ALERT:      Automatic Detention

PRODUCT      :      Tattoo Removers

PRODUCT CODE :      66V--99

HARMONIZED
CODE         :      N/A

PROBLEM      :      New Drug without a New Drug Application (NDA) (DRND)

PAC FOR
COLLECTION   :      56008H

COUNTRY      :      All

MANUFACTURER/
SHIPPER      :      All

MANUFACTURER/
SHIPPER I.D.#:      N/A


IMPORTER'S
I.D. #       :      N/A

CHARGE       :      "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 [Unapproved New Drug, Section 505(a)]."

RECOMMENDING
OFFICE       :      CDER/OTC Compliance Branch, HFD-312

REASON FOR
ALERT        : Three complaints of injury have implicated this drug as the
               source of acute inflammation, cellulitis and secondary
               infection of the skin.  All of the complaints indicated that
               the tattoo remover was received through the mail from the
               Atlanta Co., Pickering, Ontario, Canada.

                    The product was received in small plastic vials labeled in
                    part, "Tatex Tattoo Remover*** 2 1/2 cc accompanied by
                    labeling entitled, "Instructions for use of the Tatex Tattoo
                    Remover."

               Although there has been no recent detention activity of the
               Tatex brand tattoo remover, the alert remains in effect
               because of the possibility of entry which may be attempted for
               similar products from other foreign manufacturers.


INSTRUCTIONS : Detain products which claim to be tattoo removers.  Notify
               CDER/OTC Labeling Branch at 301-295-8063 when detentions of
               these products are made.

PRIORITIZATION
GUIDANCE     :      N/A

FOI          :      No purging required.



KEYWORDS     :      Tattoo remover, New Drug, Tatex Tattoo Remover, skin,
                    infection

PREPARED BY  :      Linda A. Wisniowski, DIOP, 301-443-6553.