AUTHENTICATED
`U.$. GOVERNMENT
`INFORMATION
`CPO
`
`Food and Drug Administration, HHS
`
`§349.l4
`
`Subpari A—Genera| Provisions
`
`§ 349.1 Scope.
`(a) An over-the-counter ophthalmic
`drug product in a form suitable for top-
`ical administration is generally recog-
`nized as safe and effective and is not
`misbranded if it meets each of the con-
`ditions in this part and each of the gen-
`eral conditions established in §330.1.
`(b) References in this part to regu-
`latory sections of the Code of Federal
`Regulations are to chapter I of title 21
`unless otherwise noted.
`
`§ 349.3 Definitions.
`As used in this part:
`(a) Ophthalmic drug product. A drug
`product, which should be sterile in ac-
`cordance with §200.50, to be applied to
`the eyelid or instilled in the eye.
`(b) Astringent. A locally acting phar-
`macologic agent which, by precipi-
`tating protein, helps to clear mucus
`from the outer surface of the eye.
`(c) Buffering agent. A substance which
`stabilizes the pH of solutions against
`changes produced by introduction of
`acids or bases from such sources as
`drugs, body fluids, tears, etc.
`(d) Demulcent. An agent, usually a
`water-soluble polymer, which is ap-
`plied topically to the eye to protect
`and lubricate mucous membrane sur-
`faces and relieve dryness and irrita-
`tion.
`(e) Emollient. An agent, usually a fat
`or oil, which is applied locally to eye-
`lids to protect or soften tissues and to
`prevent drying and cracking.
`(f) Eyewash, eye lotion, irrigating solu-
`tion. A sterile aqueous solution in-
`tended for washing, bathing, or flush-
`ing the eye.
`(g) Hypertonicity agent. An agent
`which exerts
`an osmotic gradient
`greater than that present in body tis-
`sues and fluids, so that water is drawn
`from the body tissues and fluids across
`semipermeable membranes. Applied
`topically to the eye, a hypertonicity
`agent creates an osmotic gradient
`which draws water out of the cornea.
`(h) Isotonicity. A state or quality in
`which the osmotic pressure in two
`fluids is equal.
`(i) Vasoconstrictor. A pharmacologic
`agent which, when applied topically to
`the mucous membranes of
`the eye,
`
`causes transient constriction of con-
`junctival blood vessels.
`
`Subpari B—Aciive Ingredients
`
`§349.10 Ophthalmic astringent.
`The active ingredient and its con-
`centration in the product is as follows:
`Zinc sulfate, 0.25 percent.
`
`§349.12 Ophthalmic demulcents.
`The active ingredients of the product
`consist of any of the following, within
`the established concentrations for each
`ingredient:
`(a) Cellulose derivatives:
`(1) Carboxymethylcellulose sodium,
`0.2 to 2.5 percent.
`(2) Hydroxyethyl cellulose, 0.2 to 2.5
`percent.
`(3) Hypromellose, 0.2 to 2.5 percent.
`(4) Methylcellulose, 0.2 to 2.5 percent.
`(b) Dextran 70, 0.1 percent when used
`with another polymeric demulcent
`agent in this section.
`(c) Gelatin, 0.01 percent.
`(d) Polyols, liquid:
`(1) Glycerin, 0.2 to 1 percent.
`(2) Polyethylene glycol 300, 0.2 to 1
`percent.
`(3) Polyethylene glycol 400, 0.2 to 1
`percent.
`(4) Polysorbate 80, 0.2 to 1 percent.
`(5) Propylene glycol, 0.2 to 1 percent.
`(e) Polyvinyl alcohol, 0.1 to 4 percent.
`(f) Povidone, 0.1 to 2 percent.
`[53 FR 7090, Mar. 4, 1988, as amended at 68 FR
`32982, June 3, 2003]
`
`§349.14 Ophthalmic emollients.
`The active ingredients of the product
`consist of any of the following:
`(a) Lanolin preparations:
`(1) Anhydrous lanolin, 1 to 10 percent
`in combination with one or more ole-
`aginous emollient agents included in
`the monograph.
`(2) Lanolin, 1 to 10 percent in com-
`bination with one or more oleaginous
`emollient agents included in the mono-
`graph.
`(b) Oleaginous ingredients:
`(1) Light mineral oil, up to 50 percent
`in combination with one or more other
`emollient agents included in the mono-
`graph.
`(2) Mineral oil, up to 50 percent in
`combination with one or more other
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`ARGENTUM PHARM. 1057
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`ARGENTUM PHARM. 1057
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