IA#66-11,   REVISED 9/21/92


Note:  Revision to this alert updates the information and reformats
the text
of the alert.


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.