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Title 21

Displaying title 21, up to date as of 9/23/2021. Title 21 was last amended 9/21/2021.

Title 21

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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. “To avoid contamination, do not touch tip of container to any surface. Replace cap after using.”

(2) For ophthalmic drug products packaged in single-use containers. “To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.”

(3) For ophthalmic drug products containing mercury compounds used as a preservative. “This product contains (name and quantity of mercury-containing ingredient) as a preservative. Do not use this product if you are sensitive to” (select one of the following: “mercury” or “(insert name of mercury-containing ingredient) or any other ingredient containing mercury).”

§ 349.55 Labeling of ophthalmic astringent drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “astringent” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “For the temporary relief of discomfort from minor eye irritations.”

(c) Warnings. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.10:

(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. The labeling of the product contains the following information under the heading “Directions”: Instill 1 to 2 drops in the affected eye(s) up to four times daily.

§ 349.60 Labeling of ophthalmic demulcent drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant” or “demulcent (lubricant)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”

(b) Indications. The labeling of the product states, under the heading “Indications,” one or more of the following phrases:

(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. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.12:

(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. The labeling of the product contains the following information under the heading “Directions”: Instill 1 or 2 drops in the affected eye(s) as needed.

§ 349.65 Labeling of ophthalmic emollient drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “lubricant” or “emollient (lubricant)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., ointment).”

(b) Indications. The labeling of the product states, under the heading “Indications,” one or more of the following phrases:

(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. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.14: “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.”

(d) Directions. The labeling of the product contains the following information under the heading “Directions”: Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

§ 349.70 Labeling of ophthalmic hypertonicity drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “hypertonicity” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “For the temporary relief of corneal edema.”

(c) Warnings. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.16:

(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. The labeling of the product contains the following information under the heading “Directions”: Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

§ 349.75 Labeling of ophthalmic vasoconstrictor drug products.

(a) Statement of identity. The labeling of the product contains the established name of the drug(s), if any, and identifies the product as a “redness reliever” or “vasoconstrictor (redness reliever)” (select one of the following: “eye” or “ophthalmic”) “(insert dosage form, e.g., drops).”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following phrase: “Relieves redness of the eye due to minor eye irritations.”

(c) Warnings. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for products containing any ingredient identified in § 349.18:

(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. The labeling of the product contains the following information under the heading “Directions”: Instill 1 to 2 drops in the affected eye(s) up to four times daily.

[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. The labeling of the product identifies the product with one or more of the following terms: “eyewash,” “eye irrigation,” or “eye irrigating solution.”

(b) Indications. The labeling of the product states, under the heading “Indications,” one of the following phrases:

(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. In addition to the warnings in § 349.50, the labeling of the product contains the following warnings under the heading “Warnings” for all eyewash products:

(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. The labeling of the product contains the following information under the heading “Directions”:

(1) For eyewash products intended for use with an eyecup. Rinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaces of cup. Fill cup half full and apply the cup to the affected eye, pressing tightly to prevent the escape of the liquid, and tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion. Rinse cup with clean water after each use.

(2) For eyewash products intended for use with a nozzle applicator. Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

[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. For a combination drug product that has an established name, the labeling of the product states the established name of the combination drug product, followed by the statement of identity for each ingredient in the combination, as established in the statement of identity sections of this part. For a combination drug product that does not have an established name, the labeling of the product states the statement of identity for each ingredient in the combination, as established in the statement of identity sections of this part.

(b) Indications. The labeling of the product states, under the heading “Indications,” the indication(s) for each ingredient in the combination, as established in the indications sections of this part.

(c) Warnings. The labeling of the product states, under the heading “Warnings,” the warning(s) for each ingredient in the combination, as established in the warnings sections of this part.

(d) Directions. The labeling of the product states, under the heading “Directions,” directions that conform to the directions established for each ingredient in the directions sections of this part. When the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not exceed any maximum dosage limits established for the individual ingredients in the applicable OTC drug monograph.

§ 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., gonioscopy, electroretinography).