Emollient eye drops: what the word means

In eye drops, an emollient is an oily active ingredient. FDA’s rules for over-the-counter eye products define it, in 21 CFR 349.3, as an agent that’s “usually a fat or oil,” applied to protect or soften tissues. Section 349.14 lists the emollients those rules allow, and light mineral oil is one of them. It’s the emollient among Quell’s three active ingredients.

Where the word comes from on a label

Over-the-counter eye drops in the United States are governed by part 349 of Title 21 of the Code of Federal Regulations, titled “Ophthalmic Drug Products for Over-the-Counter Human Use.” It works by category: it names kinds of active ingredient, lists the ingredients allowed in each, and sets what the label may say. Emollients are one of those categories, and when a Drug Facts panel lists an ingredient’s purpose as “emollient,” that’s the category it’s pointing to.

The definition in section 349.3 describes an emollient as usually a fat or oil applied locally to protect or soften tissues and keep them from drying and cracking. Notice that its wording speaks of the eyelids. Oily ingredients aren’t limited to ointments, though; Quell is a drop, and its Drug Facts panel lists one.

Which ingredients count as emollients

Section 349.14, “Ophthalmic emollients,” lists the allowed ingredients in two groups, each with its own conditions on strength and combination:

• Lanolin preparations: anhydrous lanolin and lanolin, which the rule allows only in combination with one or more of the oily emollients below.
• Oleaginous, meaning oily, ingredients: light mineral oil, mineral oil, paraffin, petrolatum, white ointment, white petrolatum, white wax and yellow wax.

Several names on that list, such as petrolatum and white petrolatum, are the familiar greasy bases of eye ointments. Light mineral oil is a thinner oil than those. The label shows how much of each active is in a given product; Quell’s panel lists Light Mineral Oil (0.5%).

Emollient vs. lubricant eye drops

“Lubricant eye drops” is a description, not a separate legal category. On a Drug Facts panel, “lubricant” is the purpose given to water-friendly ingredients like glycerin and polysorbate 80, which part 349 groups as demulcents. So a drop sold as a lubricant eye drop may contain only demulcents, or demulcents plus an emollient. The way to tell is to read the Purpose column beside each active ingredient.

• Demulcents (labeled “lubricant”): usually water-soluble, and they coat and lubricate the eye’s surface.
• Emollients (labeled “emollient”): usually a fat or oil, and they bring an oily component.

What is a demulcent in eye drops? covers the water-friendly side in detail.

Emollient lubricant eye drops

Some drops combine both kinds, and Quell is one of them. Its active ingredients are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%). The panel gives glycerol and polysorbate 80 the purpose “lubricant” and light mineral oil the purpose “emollient.” The pairing reflects the tear film itself, which has a watery layer under a thin oily one. Quell is designed to reinforce the tear film’s oil layer to help reduce moisture loss, and its inactive ingredients add natural oils, including emu oil. That oily content is also why the solution isn’t clear: Product appears as a milky brown solution.

Light mineral oil in eye drops looks at that one ingredient on its own.

Emollient eye drops: side effects and warnings

The place to look for warnings is the Drug Facts panel of the specific product, not a general article about a category. Quell’s warnings read: Caution should be used in those with egg or bird allergies — For use in the eyes only. The emu oil among its inactive ingredients is the reason for the egg and bird caution. Its stop-use section reads: Stop use and ask a doctor if you feel eye pain or changes in your vision, if irritation or redness continues, or if the condition worsens or persists for 72 hours.

If you’re weighing an emollient drop because of contact lenses, other eye drops you use, or a child’s eyes, Quell’s label doesn’t cover those situations. Ask your eye doctor or pharmacist first.

How to spot an emollient on a Drug Facts panel

• Find the Active ingredients section at the top of the panel.
• Read the Purpose column next to each ingredient.
• “Emollient” there means an oily ingredient from the part 349 list; “lubricant” usually means a demulcent.
• Check the strength printed beside each one, since the rule limits how much may be used.
• Compare the inactive ingredients too, since they can add oils of their own that aren’t counted as actives.

The full panel for Quell is on the Drug Facts page, and the active ingredients section explains how that part of any label is laid out.