[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 From the U.S. Government Printing Office via GPO Access
 [CITE: 21CFR73.3115]
 
 [Page 386]
 
                         TITLE 21--FOOD AND DRUGS
 
 CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                 SERVICES
 
 PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                        Subpart D--Medical Devices
 
 Sec. 73.3115  2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.
 
     (a) Identity. The color additive2-[[2,5-diethoxy-4-[(4-
 methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol is formed in situ in
 soft (hydrophilic) contact lenses.
     (b) Uses and restrictions. The color additive 2-[[2,5-diethoxy-4-
 [(4-methylphenyl)thio]phenyl]azo]-1,3,5-benzenetriol may be safely used
 to mark soft (hydrophilic) contact lenses with the letter R or the
 letter L for identification purposes subject to the following
 restrictions:
     (1) The quantity of the color additive does not exceed
     1.1 x 10<SUP>-7</SUP> grams in a soft (hydrophilic) contact lens.
     (2) When used as specified in the labeling, there is no measurable
 migration of the color additive from the contact lens to the surrounding
 ocular tissue.
     (3) Authorization for this use shall not be construed as waiving any
 of the requirements of section 510(k) and 515 of the Federal Food, Drug,
 and Cosmetic Act with respect to the contact lens in which the color
 additive is used.
     (c) Labeling. The label of the color additive shall conform to the
 requirements of Sec. 70.25 of this chapter.
     (d) Exemption from certification. Certification of this color
 additive is not necessary for the protection of the public health, and
 therefore the color additive is exempt from the certification
 requirements of section 721(c) of the act.
 
 [48 FR 22706, May 20, 1983]