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118 Fda Ban/Alert Against Tatex USA's Do-It-Yourself Kit




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This article is from the Tattoo FAQ, by Stan Schwarz with numerous contributions by others.

118 Fda Ban/Alert Against Tatex USA's Do-It-Yourself Kit

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




 

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