What is the OTC monograph for eye drops?

The OTC monograph for eye drops is FDA’s rulebook for over-the-counter ophthalmic products. Originally codified as 21 CFR Part 349, “Ophthalmic Drug Products for Over-the-Counter Human Use,” it lists permitted active ingredients by category, their concentration ranges, and required label wording. Under the 2020 CARES Act it became a final administrative order, now called OTC Monograph M018. Products that follow it don’t need individual FDA approval.

What a monograph is

Most new drugs reach the market through an application that FDA reviews product by product. Many over-the-counter medicines work differently. For categories of OTC drugs, FDA publishes a monograph: a set of conditions covering which active ingredients may be used, in what amounts, for what uses, and with what label statements. A product that meets every condition can be marketed without its own approval. One that strays outside them, by adding an ingredient that isn’t listed or making a claim the monograph doesn’t allow, can’t rely on the monograph.

That’s why a monograph eye drop’s label doesn’t claim an individual FDA approval, and why the claims on these labels look so similar from brand to brand. Our guide to how over-the-counter eye drops are regulated covers the bigger picture, including manufacturing rules.

21 CFR Part 349: the ophthalmic monograph

The eye drop monograph was published in the Code of Federal Regulations as Part 349. The government’s own archive at govinfo.gov still carries the text. It’s organized into three parts:

• Subpart A, general provisions, including definitions of terms like demulcent and emollient.
• Subpart B, active ingredients, grouped by category.
• Subpart C, labeling, with required wording for each category.

Subpart B lists these categories: an ophthalmic astringent, ophthalmic demulcents, ophthalmic emollients, an ophthalmic hypertonicity agent, ophthalmic vasoconstrictors, and eyewashes, followed by a section on which active ingredients may be combined.

How the CARES Act changed it

For decades, changing an OTC monograph meant a slow, multi-step rulemaking process. The Coronavirus Aid, Relief, and Economic Security Act, enacted March 27, 2020, added section 505G to the Federal Food, Drug, and Cosmetic Act and reformed that system. Final monographs were deemed final administrative orders on the day the law took effect.

FDA now publishes the ophthalmic order as OTC Monograph M018, “Ophthalmic Drug Products for OTC Human Use,” on its website. The content carried over, and FDA can now amend it by administrative order instead of full rulemaking. The section numbers changed format too: what was 349.12 for demulcents corresponds to M018.12.

Where Quell’s active ingredients fit

Quell’s active ingredients are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%). Each appears in the monograph’s lists:

• Glycerin, the name the monograph uses for glycerol, is listed among the ophthalmic demulcents as a liquid polyol. Quell’s label shows it as Glycerol (1.0%).
• Polysorbate 80 is listed in the same group of liquid polyol demulcents. On the label: Polysorbate 80 (1.0%).
• Light mineral oil is listed among the ophthalmic emollients as an oleaginous ingredient. On the label: Light Mineral Oil (0.5%).

The monograph defines a demulcent as an agent, usually a water-soluble polymer, that protects and lubricates mucous membrane surfaces and relieves dryness and irritation, and an emollient as an agent, usually a fat or oil, that protects or softens tissues. Our guides on what a demulcent is and emollient eye drops go into each, and the active ingredients section explains how they appear on the label. If the glycerin and glycerol names confuse you, see glycerin vs. glycerol.

The inactive ingredients, such as emu oil and manuka honey, aren’t active ingredients and so aren’t in the monograph’s active-ingredient lists. They’re listed separately on the label: Caprylyl Glycol, Dead Sea Salt (Sodium Chloride), Emu Oil, Glyceryl Laurate, Glyceryl Undecylenate, Manuka Honey, Polaxamer 188, Sterile Water, Terminalia Chubula and Tromethamine.

The label wording comes from the monograph too

Monograph labeling isn’t freeform. Subpart C gives the statements a product may use for its indications and the warnings it must carry. Quell’s Uses line, For use as a protectant against further irritation or to relieve dryness of the eye, matches one of the indication statements the monograph lists for demulcent and emollient products. The tip warning, Do not touch tip of bottle to any surface to avoid contamination, follows the general labeling section, and the 72-hour stop-use statement and the color-change warning come from the demulcent labeling section.

That shared source is why lubricating drops tend to say almost the same things. It also explains what the labels don’t say: no promises about how long relief continues, and no claims outside the listed uses. Our guide on why the label mentions 72 hours looks at one of those warnings closely.

Reading a monograph eye drop label

• Active ingredients appear first, each with its amount and its category, such as “lubricant” or “protectant.”
• Uses repeat a monograph indication word for word or nearly so.
• Warnings include the tip warning, a stop-use statement and a do-not-use line.
• Directions give the dose and how often. Quell’s: Apply 1 drop 3 times per day in each eye.
• Inactive ingredients and storage come last. Quell’s storage line: Store between 15° to 30°C (59° to 86°F).

You can read Quell’s whole panel on our Drug Facts page, and how to read an eye drop Drug Facts label walks through each box.