PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted. Subpart A—General Provisions § 349.1 Scope. (a) An over-the-counter ophthalmic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1. (b) References in this part to regulatory 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. (b) Astringent. (c) Buffering agent. (d) Demulcent. (e) Emollient. (f) Eyewash, eye lotion, irrigating solution. (g) Hypertonicity agent. (h) Isotonicity. (i) Vasoconstrictor. Subpart B—Active Ingredients § 349.10 Ophthalmic astringent. The active ingredient and its concentration 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 oleaginous emollient agents included in the monograph. (2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph. (b) Oleaginous ingredients: (1) Light mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph. (2) Mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph. (3) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the monograph. (4) Petrolatum, up to 100 percent. (5) White ointment, up to 100 percent. (6) White petrolatum, up to 100 percent. (7) White wax, up to 5 percent in combination with one or more other emollient agents included in the monograph. (8) Yellow wax, up to 5 percent in combination with one or more other emollient agents included in the monograph. § 349.16 Ophthalmic hypertonicity agent. The active ingredient and its concentration in the product is as follows: Sodium chloride, 2 to 5 percent. § 349.18 Ophthalmic vasoconstrictors. The active ingredient of the product consists of one of the following, within the established concentration for each ingredient: (a) Ephedrine hydrochloride, 0.123 percent. (b) Naphazoline hydrochloride, 0.01 to 0.03 percent. (c) Phenylephrine hydrochloride, 0.08 to 0.2 percent. (d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent. § 349.20 Eyewashes. The active ingredient of the product is purified water. The product also contains suitable tonicity agents to establish isotonicity with tears, suitable agents for establishing pH and buffering to achieve the same pH as tears, and a suitable preservative agent. [68 FR 7921, Feb. 19, 2003] § 349.30 Permitted combinations of active ingredients. The following combinations are permitted provided each active ingredient is present within the established concentration, and the product is labeled in accordance with § 349.79. (a) Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18. (b) Any two or three ophthalmic demulcent active ingredients identified in § 349.12 may be combined. (c) Any single ophthalmic demulcent active ingredient identified in § 349.12 or any ophthalmic demulcent combination identified in paragraph (b) of this section may be combined with any single ophthalmic vasoconstrictor identified in § 349.18. (d) Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18 and any single ophthalmic demulcent identified in § 349.12 or ophthalmic demulcent combination identified in paragraph (b) of this section. (e) Any two or more emollient active ingredients identified in § 349.14 may be combined as necessary to give the product proper consistency for application to the eye. Subpart C—Labeling § 349.50 Labeling of ophthalmic drug products. (a) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this part. (b) Where applicable, indications in this part applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this part, may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (c) The labeling of the product contains the following warnings, under the heading “Warnings”: (1) For ophthalmic drug products packaged in multi-use containers. (2) For ophthalmic drug products packaged in single-use containers. (3) For ophthalmic drug products containing mercury compounds used as a preservative. § 349.55 Labeling of ophthalmic astringent drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.” (2) “If solution changes color or becomes cloudy, do not use.” (d) Directions. § 349.60 Labeling of ophthalmic demulcent drug products. (a) Statement of identity. (b) Indications. (1) “For the temporary relief of burning and irritation due to dryness of the eye.” (2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.” (3) “For use as a protectant against further irritation or to relieve dryness of the eye.” (4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye.” (c) Warnings. (1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.” (2) “If solution changes color or becomes cloudy, do not use.” (d) Directions. § 349.65 Labeling of ophthalmic emollient drug products. (a) Statement of identity. (b) Indications. (1) “For the temporary relief of burning and irritation due to dryness of the eye.” (2) “For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.” (3) “For use as a protectant against further irritation or to relieve dryness of the eye.” (4) “For use as a lubricant to prevent further irritation or to relieve dryness of the eye.” (c) Warnings. (d) Directions. § 349.70 Labeling of ophthalmic hypertonicity drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “Do not use this product except under the advice and supervision of a doctor. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.” (2) “This product may cause temporary burning and irritation on being instilled into the eye.” (3) “If solution changes color or becomes cloudy, do not use.” (d) Directions. § 349.75 Labeling of ophthalmic vasoconstrictor drug products. (a) Statement of identity. (b) Indications. (c) Warnings. (1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.” (2) “Ask a doctor before use if you have [in bold type] narrow angle glaucoma.” (3) “Overuse of this product may produce increased redness of the eye.” (4) “If solution changes color or becomes cloudy, do not use.” (5) “When using this product [in bold type] pupils may become enlarged temporarily.” (d) Directions. [53 FR 7090, Mar. 4, 1988, as amended at 65 FR 38428, June 21, 2000] § 349.78 Labeling of eyewash drug products. (a) Statement of identity. (b) Indications. (1) “For” (select one of the following: “flushing,” “irrigating,” “cleansing,” “washing,” or “bathing”) “the eye to remove” (select one or more of the following: “loose foreign material,” “air pollutants (smog or pollen),” or “chlorinated water”). (2) “For” (select one of the following: “flushing,” “irrigating,” “cleansing,” “washing,” or “bathing”) “the eye to help relieve” (select one or more of the following: “irritation,” “discomfort,” “burning,” “stinging,” “smarting,” or “itching”) “by removing” (select one or more of the following: “loose foreign material,” “air pollutants (smog or pollen),” or “chlorinated water”). (c) Warnings. (1) “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor.” (2) “Obtain immediate medical treatment for all open wounds in or near the eyes.” (3) “If solution changes color or becomes cloudy, do not use.” (d) Directions. (1) For eyewash products intended for use with an eyecup. (2) For eyewash products intended for use with a nozzle applicator. [53 FR 7090, Mar. 4, 1988, as amended at 68 FR 7921, Feb. 19, 2003] § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. (b) Indications. (c) Warnings. (d) Directions. § 349.80 Professional labeling. The labeling of any OTC ophthalmic demulcent drug product provided to health professionals (but not to the general public) may contain instructions for the use of these products in professional eye examinations ( i.e.