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rec.arts.bodyart: Tattoo FAQ 7/9--General care/removal
Section - FDA BAN/ALERT AGAINST TATEX USA'S DO-IT-YOURSELF KIT

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Top Document: rec.arts.bodyart: Tattoo FAQ 7/9--General care/removal
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The following, brought to my attention by Mike <silicon@cris.com>, is a
copy of an FDA alert dated September 1992  against the method of
chemical tattoo removal being marketed by Tatex,  Inc. based in
Pickering, Ontario (Canada) and marketed in the US out of Las Vegas,
Nevada. I have no reason to doubt Mike's intentions in forwarding this
alert to me. From what Mike tells me, it's possible that Tatex is a weak
acid or peroxide formula that eats away at your skin. He says he
believes the FDA alert is due to their not having completed necessary
tests. The following is the alert in its entirety. I'll let the readers
decide for themselves whether this stuff is appropriate or not.
(Reformatted for ease of readability.)

I recently received an email from the makers of Tatex, asking me to
remove this section.  I checked, and the FDA alert is still in effect, 
having been updated as recently as October, 1999, so this section
still stands.

* * * * *

FDA IA#66-11,   REVISED 9/21/92
TYPE OF ALERT: Automatic Detention
PRODUCT:       Tattoo Removers
PRODUCT CODE:  66V--99
PROBLEM:       New Drug without a New Drug Application (NDA) (DRND)
PAC FOR COLLECTION: 56008H
COUNTRY:       All
MANUFACTURER/SHIPPER: All
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.
KEYWORDS: Tattoo remover, New Drug, Tatex Tattoo Remover, skin, 
          infection
PREPARED BY  : Linda A. Wisniowski, DIOP, 301-443-6553


User Contributions:

Yusuph
Report this comment as inappropriate
Aug 16, 2012 @ 12:00 am
I real to know much the history of tattoo, from the begin. Please send for me the all details/summary or imformation of tattoo. You can find me also on facebook as Toto mbata chico. Thank u

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Top Document: rec.arts.bodyart: Tattoo FAQ 7/9--General care/removal
Previous Document: CAN A TATTOO BE REMOVED?
Next Document: PROGRAMS FOR TATTOO REMOVAL IN JUVENILES

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