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IA#66-11, REVISED 9/21/92
Note: Revision to this alert updates the information and reformats
of the alert.
TYPE OF ALERT: Automatic Detention
PRODUCT : Tattoo Removers
PRODUCT CODE : 66V--99
CODE : N/A
PROBLEM : New Drug without a New Drug Application (NDA) (DRND)
COLLECTION : 56008H
COUNTRY : All
SHIPPER : All
SHIPPER I.D.#: N/A
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
Section 801(a)(3) in that it appears to be a new
the meaning of Section 201(p) without an approved
application [Unapproved New Drug, Section 505(a)]."
OFFICE : CDER/OTC Compliance Branch, HFD-312
ALERT : Three complaints of injury have implicated this drug
source of acute inflammation, cellulitis and
infection of the skin. All of the complaints
the tattoo remover was received through the mail
Atlanta Co., Pickering, Ontario, Canada.
The product was received in small plastic vials
part, "Tatex Tattoo Remover*** 2 1/2 cc accompanied
labeling entitled, "Instructions for use of the
Although there has been no recent detention activity
Tatex brand tattoo remover, the alert remains in
because of the possibility of entry which may be
similar products from other foreign manufacturers.
INSTRUCTIONS : Detain products which claim to be tattoo removers.
CDER/OTC Labeling Branch at 301-295-8063 when
these products are made.
GUIDANCE : N/A
FOI : No purging required.
KEYWORDS : Tattoo remover, New Drug, Tatex Tattoo Remover,
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.