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).”
Indications. The labeling of the product states, under the heading “Indications,” one or more of the following phrases:
“For the temporary relief of burning and irritation due to dryness of the eye.”
“For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.”
“For use as a protectant against further irritation or to relieve dryness of the eye.”
“For use as a lubricant to prevent further irritation or to relieve dryness of the eye.”
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.”
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.
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with easy access to affordable legal services through a network of independent law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our network law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.