Are eye drops sterile?

Yes. Federal regulations require eye drops to be sterile. FDA’s rule for ophthalmic preparations, 21 CFR 200.50, says products for use in the eye should be sterile and that containers must be sterile when filled and closed. Once you open the bottle, keeping it clean is up to you: don’t touch the tip to anything, and use only an intact, sealed bottle.

What federal rules say

The regulation on ophthalmic preparations, published in Title 21 of the Code of Federal Regulations at section 200.50 and available on govinfo.gov, covers drugs meant for the eye, including cleansing products. It says these preparations should be sterile, and that their containers must be sterile at the time of filling and closing.

The same section requires over-the-counter eye products to be sealed so they can’t be opened without breaking the seal, and to follow federal tamper-resistant packaging rules. That’s why bottles come with a seal you break the first time you use them.

Sterile in the box, clean in your hand

Sterile describes the product as it leaves the factory, sealed. After you open the bottle, it’s exposed to the air, your hands and anything the tip touches. The label’s handling line exists for exactly this reason: Do not touch tip of bottle to any surface to avoid contamination.

• Wash your hands before using drops.
• Don’t let the tip touch your eye, lashes, fingers, or any surface.
• Put the cap back on right after use.
• Set the cap down on a clean tissue, top side down, or hold it in your hand.
• Don’t share a bottle with anyone else.
• Don’t transfer drops into another container.

Where you keep an open bottle matters too. A steamy bathroom shelf, a gym bag shared with sweaty clothes, or a jacket pocket full of crumbs and coins all bring the tip closer to things you’d rather keep away from your eyes. A clean drawer, a small zip pouch, or the original carton keeps the cap and tip protected between uses. If you carry a bottle around, check that the cap is snapped on fully before it goes into a pocket or bag.

Preservative-free and sterile

Many eye drops contain preservatives, which help limit contamination after a bottle is opened. Quell is preservative-free, so careful handling matters even more. Our guide on what preservative-free means explains the difference.

Preservative-free doesn’t mean less sterile. Both kinds of eye drops have to meet the same federal sterility requirement when they’re packaged. The difference is what happens after opening, which is why the handling line and clean hands matter.

What’s in Quell

Quell’s active ingredients are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%). It has 10 inactive ingredients: Caprylyl Glycol, Dead Sea Salt (Sodium Chloride), Emu Oil, Glyceryl Laurate, Glyceryl Undecylenate, Manuka Honey, Polaxamer 188, Sterile Water, Terminalia Chubula and Tromethamine. Sterile water is one of them, which is the base the other ingredients are carried in. You can read the full list with the rest of the label on our Drug Facts page.

The label also describes how it looks: Product appears as a milky brown solution. In plain terms: The eye drops have a naturally milky-brown appearance. This is normal and does not indicate a problem with the product.

Check the seal before you open it

Since the seal is part of how the product stays sterile until you use it, check it before the first drop. If the tamper seal is broken, missing or looks tampered with when your order arrives, don’t use the bottle. Our guide on what to do if the tamper seal is broken explains how to get a replacement; damaged, incorrect and broken-seal orders are replaced.

Also check the expiration date printed on the bottle and carton. Don’t use drops past that date.

When not to use a bottle

The label’s “Do not use” line reads: If this product changes color. Since Quell is naturally milky brown, compare it to how it looked when you first opened it. Other reasons to set a bottle aside:

• The tip touched your eye, a counter, or another surface.
• The bottle was stored outside the label’s range: Store between 15° to 30°C (59° to 86°F).
• It’s past its expiration date.
• Someone else used it.

If your eye feels worse after a drop

Stop using the drop. The label is direct: 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. Our list of eye symptoms that need a doctor covers the signs that need prompt attention. If you swallow the product by mistake, the label says: If swallowed, get medical help or contact a Poison Control Center immediately.