Source: https://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm
Timestamp: 2019-04-20 04:41:34+00:00

Document:
Notice: This document is not intended to be used as a substitute for the regulations that list color additives for use in the United States and the conditions imposed on their use in food, drugs, cosmetics, and medical devices, respectively. These regulations are located in Title 21 of the Code of Federal Regulations Parts 73, 74, 81 and 82. For approved conditions of use, the reader should refer to the regulation for the specific color additive of interest. Please note that color additives listed for use in drugs or cosmetics are not permitted for use in eye area products, injected products, or surgical sutures, unless the regulation for the color additive so states in the uses and restrictions paragraph. In this document, all color additives listed for suture use can be found in the table of color additives approved for use in medical devices. Additional information on color additives can be obtained from the Color Additive Status list. Important clarifications are detailed in the End Notes section.
§74.203 FD&C Green No. 3 ---- 1982 Foods generally.
§74.250 Orange B(3) ---- 1966 Casings or surfaces of frankfurters and sausages; NTE(7) 150 ppm (by wt).
§74.302 Citrus Red No. 2 ---- 1963 Skins of oranges not intended or used for processing; NTE(7) 2.0 ppm (by wt).
§73.1010 Alumina (dried aluminum hydroxide) 1967 Drugs generally (5).
§73.1030 Annatto extract 1963 Ingested drugs generally(5); external drugs(6) including eye area use.
§73.1070 Calcium carbonate 1967 Drugs generally (5).
§73.1075 Canthaxanthin(3) 1969 Ingested drugs generally (5).
§73.1095 β-Carotene 1964 Ingested drugs generally(5).
1977 Externally applied drugs(6) including eye area use.
§73.1100 Cochineal extract 1969 Ingested and externally applied drugs(6).
§73.1162 Bismuth oxychloride 1977 Externally applied drugs (6) including eye area use.
§73.1200 Synthetic iron oxide 1966 Ingested or topically applied drugs(6) ingested dosage by man NTE(7) 5 mg/d (as Fe).
§73.1298 Ferric ammonium ferrocyanide 1977 Externally applied drugs(6) including eye area use.
§73.1299 Ferric ferrocyanide 1977 Externally applied drugs including(6) eye area use.
§73.1326 Chromium hydroxide green 1977 Externally applied drugs(6) including eye area use.
§73.1327 Chromium oxide greens 1977 Externally applied drugs(6) including eye area use.
§73.1329 Guanine 1977 Externally applied drugs(6) including eye area use.
§73.1350 Mica-based pearlescent pigments (3) 2006 Ingested drugs NTE(7) 3%. Iron NTE(7)55 wt %.
§73.1400 Pyrophyllite 1966 Externally applied drugs(6).
§73.1496 Mica 1977 Externally applied drugs(6) including eye area use.
§73.1550 Talc 1967 Drugs generally (5).
§73.1575 Titanium dioxide 1966 Drugs generally(5) including eye area use .
§73.1645 Aluminum powder 1977 Externally applied drugs(6) including eye area use.
§73.1646 Bronze powder 1977 Externally applied drugs(6) including eye area use.
§73.1647 Copper powder 1977 Externally applied drugs(6) including eye area use.
§73.1991 Zinc oxide 1977 Externally applied drugs(6) including eye area use.
§74.1254 D&C Orange No. 4 1977 Externally applied drugs (6) .
§74.1255 D&C Orange No. 5 1984 Externally applied drugs (6) (NTE(7) 5 mg/daily dose of drug).
§74.1260 D&C Orange No. 10 1981 Externally applied drugs (6) .
§74.1261 D&C Orange No. 11 1981 Externally applied drugs (6) .
§74.1602 D&C Violet No. 2 1976 Externally applied drugs(6) .
§74.1705 FD&C Yellow No. 5 1969 Ingested drugs generally(5).
1985 Externally applied drugs(6) .
§74.1706 FD&C Yellow No. 6 1986 Drugs generally (5).
§74.1707 D&C Yellow No. 7 1976 Externally applied drugs(6) .
§74.1707a Ext. D&C Yellow No. 7 1976 Externally applied drugs(6) .
§74.1708 D&C Yellow No. 8 1976 Externally applied drugs(6) .
§74.1710 D&C Yellow No. 10 1983 Drugs generally (5).
§74.1711 D&C Yellow No. 11 1976 Externally applied drugs(6) .
§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.
§73.3105 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.
§73.3107 Carbazole violet(3) 1988 Contact lenses.
§73.3110a Chromium-cobalt-aluminum oxide(3) 1988 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) 1.1x10-7 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.
§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.
§74.3045 [Phthalocyaninato(2-)] copper 1969 Polypropylene sutures NTE(7) 0.5%.
1985(3) Polybutester sutures NTE(7) 0.5%.
1987(3) Haptics for intraocular lens NTE(7) 0.5%.
1990(3) Polybutylene terephthalate sutures NTE(7) 0.5%.
1999(3) Poly(vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene) nonabsorbable sutures.
NTE(7) 0.2 percent in absorbable sutures from homopolymers of glycolide.
1999 (3) NTE(7) 0.2 percent of intraocular lens haptics.
NTE(7) 0.15 percent by weight of meniscal tacks.
§74.3710 D&C Yellow No. 10 1987(3) Contact lenses.
The year approved is based on the date listed in the "Confirmation of Effective Date" notice for the action as published in the Federal Register.
NTE - not to exceed.
To access regulations from the Government Printing Office Website, click on the hyperlinks below. This opens the Electronic Code of Federal Regulations . Select the desired section below.

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