Summary of Color Additives for Use in the United States

Color Additives Approved for Use in Medical Devices
Part 73, Subpart D: Color additives exempt from batch certification 21 CFR Section Straight Color Year(2)Approved Uses and Restrictions §73.1015 Chromium-cobalt-aluminum oxide 1974 Linear polyethylene surgical sutures NTE(7) 2% general surgery. §73.1025 Ferric ammonium citrate 1973 With pyrogallol for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. §73.1375 Pyrogallol 1973 With ferric ammonium citrate for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. §73.1410 Logwood extract 1977 For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE(7) 1% general and ophthalmic surgery. §73.3100 1,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers(3) 1996 Contact lenses §73.3105 1,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione(3) 1984 Contact lenses. §73.3106 1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3) 1990 Contact lenses. §73.3106 1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3) 1993 Added copolymer, renamed. §73.3106 1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3) 1995 Additional copolymer. §73.3107 Carbazole violet(3) 1988 Contact lenses. §73.3110 Chlorophyllin-copper complex, oil soluble(3) 1984 Bone cement only NTE(7) 0.003%. §73.3110a Chromium-cobalt-aluminum oxide(3) 1988 Contact lenses. §73.3111 Chromium oxide greens(3) 1986 Contact lenses. §73.3112 C.I. Vat Orange 1(3) 1985 Contact lenses. §73.3115 2-[[2,5-Diethoxy- 4-[(4-methylphenyl)thiol] phenyl]azo] -1,3,5-benzenetriol(3) 1983 Formed in situ in soft contact lenses to mark L and R NTE(7) 1.1×10-7 g/lens. §73.3117 16,23-Dihydrodinaphtho [2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole- 5,10,15,17,22,24-hexone(3) 1983 Contact lenses. §73.3118 N,N’-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide(3) 1983 Contact lenses. §73.3119 7,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone(3) 1983 Contact lenses. §73.3120 16,17-Dimethoxydinaphtho (1,2,3-cd:3′,2′,1′-lm) perylene-5,10-dione(3) 1983 Contact lenses. §73.3121 Poly(hydroxyethyl methacrylate) -dye copolymers(3): one or more of (1) Reactive Black 5 1984 Contact lenses. (2) Reactive Blue 21 1984 (3) Reactive Orange 78 1984 (4) Reactive Yellow 15 1984 (5) Reactive Blue No. 19 1985 (6) Reactive Blue No. 4 1985 (7) C.I. Reactive Red 11 1985 (8) C.I. Reactive Yellow 86 1985 (9) C.I. Reactive Blue 163 1985 (10) C.I. Reactive Red 180 1993 §73.3122 4-[(2,4-dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one(3) 1986 Contact lenses. §73.3123 6-Ethoxy-2- (6-ethoxy-3-oxobenzo[b] thien-2(3H)- ylidene) benzo[b]thiophen- 3(2H)-one(3) 1986 Contact lenses. §73.3124 Phthalocyanine green(3) 1986 Contact lenses. §73.3125 Iron oxides(3) 1986 Contact lenses. §73.3126 Titanium dioxide(3) 1986 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (1) C.I. Reactive Red 180 1993 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (2) C.I. Reactive Black 5 1993 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (3) C.I. Reactive Orange 78 1993 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (4) C.I. Reactive Yellow 15 1993 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (5) C.I. Reactive Blue No. 19 1993 Contact lenses. §73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (6) C.I. Reactive Blue 21 1993 Contact lenses. §73.3128 Mica-based pearlescent pigments(3) 2002 Contact lenses §73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69)(3) 2011 Contact lenses

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