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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 See reader questions & answers on this topic! - Help others by sharing your knowledge 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: 1 Yusuph 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 Comment about this article, ask questions, or add new information about this topic: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 Part1 - Part2 - Part3 - Part4 - Part5 - Part6 - Part7 - Part8 - Part9 - Single Page [ Usenet FAQs | Web FAQs | Documents | RFC Index ] Send corrections/additions to the FAQ Maintainer: stan@cosmo.pasadena.ca.us
Last Update March 27 2014 @ 02:11 PM
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