Quick facts
- United States: a lubricant eye drop sold without a prescription sits in the demulcent monograph at 21 CFR 349.12 or the emollient monograph at 21 CFR 349.14, depending on whether it draws water or slows evaporation.
- United States: the demulcent monograph sets a concentration range for each active ingredient — carboxymethylcellulose sodium and hypromellose at 0.2 to 2.5 percent, polyvinyl alcohol at 0.1 to 4 percent, povidone at 0.1 to 2 percent.
- United States: the emollient monograph lists light mineral oil up to 50 percent and white petrolatum up to 100 percent, and requires an oily agent to be used with another agent in the monograph.
- Canada: an artificial tear is authorised as a drug and carries a Drug Identification Number; a Health Canada record describing the category is filed as "LUBRICANT EYE DROPS / ARTIFICIAL TEARS" in the Drug and Health Product Portal.
- Both countries: a dry eye is managed first with a lubricant and, where the meibomian glands are involved, with a warm compress; the drop and the compress do different jobs.
- Canada: regulation text cited here is current to 2026-10-03; the American lubricant monograph sections date from 53 FR 7090, March 4, 1988.
A dry eye is one of the most common reasons a patient reaches for a bottle rather than a prescription. The bottle looks the same in both countries and the two systems behind it do not work the same way. On one side a lubricant is a category; on the other it is a product with its own number. For a clinic buyer, the split decides what a substitute is, what a shelf label may say, and what happens when a line is reformulated.
What separates a demulcent from an emollient in a dry eye?
The mechanism separates them, and a shelf order that mixes the two is harder to keep than one that does not.
A demulcent attracts and holds water on the surface of the eye. The ingredients are the cellulose derivatives and synthetic polymers — carboxymethylcellulose sodium, hydroxyethyl cellulose, hypromellose, methylcellulose, gelatin, the liquid polyols, polyvinyl alcohol and povidone. Each carries a concentration range in 21 CFR 349.12, and those ranges are the reason two bottles with the same active ingredient can feel different.
An emollient slows evaporation. The ingredients are the oily agents — light mineral oil, mineral oil, paraffin, petrolatum, white ointment, white petrolatum and the waxes — and 21 CFR 349.14 requires most of them to be used in combination with another agent in the monograph rather than alone.
The American Academy of Ophthalmology sets out the clinical picture in its dry eye resource, which separates a water-deficient eye from an evaporative one. That distinction is what a buyer is really reading a shelf against: a water-deficient eye needs a demulcent and an evaporative eye leans on an emollient.
| Product type | Monograph section | Action | Ingredient example |
|---|---|---|---|
| Demulcent | 21 CFR 349.12 | Attracts and holds water | Hypromellose 0.2 to 2.5 percent |
| Emollient | 21 CFR 349.14 | Slows evaporation | Light mineral oil up to 50 percent |
| Combined lubricant | Both sections | Does both jobs | A demulcent with a lipid phase |
| Warm compress | Device route | Warms the lid margin | A reusable or single-use compress |
Are artificial tears a drug or a device in each country?
They take the drug route in both countries, and the difference is in how the drug route is entered.
In Canada an artificial tear is a drug, and it reaches the market through an authorisation that assigns it a Drug Identification Number. A Health Canada record for lubricant eye drops and artificial tears is filed in the Drug and Health Product Portal under that description. The portal is the same one that carries the medical device side of the portfolio at Health Canada, drug and health product portal, so a buyer checking both a drop and an eye shield looks in one place.
In the United States a lubricant that matches the monograph enters the market under the category rather than under a product decision. The practical difference for a clinic is what changes when a supplier changes a formulation. Inside the American monograph, a change that stays within the listed concentrations is handled as a labelling matter. On the Canadian side the product's own authorisation is what governs.
The scope of the ophthalmic instrument standards that sit beside these products is carried in ISO 15004-1:2020, and the optics vocabulary in ISO 18369-1:2017.
| Item | Canada | United States |
|---|---|---|
| Route for a lubricant drop | Drug authorisation with a Drug Identification Number | OTC ophthalmic monograph |
| Governing list | The product's own authorisation | 21 CFR 349.12 and 349.14 |
| What a reformulation touches | The product authorisation | The monograph conditions |
| Record a buyer can look up | The product record in the portal | The monograph section text |
Does the drop matter if the meibomian glands are the problem?
No, and this is the point most often missed when a shelf is ordered only around bottles.
An evaporative dry eye is a lid-margin problem. The meibomian glands along the lid edge supply the oily layer that keeps the tear film from evaporating, and when they are blocked a lubricant drop sits on an unstable film. The management that helps is warmth applied to the closed lid, which is why a warm compress is stocked beside the lubricant rather than instead of it.
A reusable compress is a device rather than a drug, so a clinic that stocks both is ordering across two routes at once. The American Academy of Ophthalmology's dry eye resource names warm compresses among the routine measures for lid-margin disease, and a clinic that separates the bottle shelf from the compress shelf keeps the two routes from being confused on the order.
How should a clinic store and record a lubricant shelf?
By lot and by opening date, because a lubricant that has been open too long is a comfort complaint waiting to happen.
- Keep the drop away from the compress. A drug and a device are logged differently, so a mixed drawer produces a mixed record.
- Record the lot on opening. A lubricant bottle is a multi-use container, and the opening date is the field that answers a patient's question about how long it has been in the room.
- Separate preserved from preservative-free. A preservative-free unit dose has a shorter after-opening life than a preserved bottle, and the two need different handling notes.
- Write the device class beside the compress. A reusable compress carries the maintenance instruction for its own cleaning.
- Keep the reference with the shelf. The monograph section for a drop and the device reference for a compress are what turn a stock order into a supply that can be defended.
Which consumables does an eye room restock?
A dry eye room runs on the same consumables as the rest of the practice, and the two that sit closest to the lubricant shelf are the paper and the swab. The exam table paper is replaced between patients, and the double-tipped cotton swabs cover lid margin cleaning. A practice that runs its own steriliser pairs the sterilization monitoring collection with the biological indicator 5-pack trial. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
A shelf built on those five habits answers a comfort complaint and a records request from the same page.
Sources
- 21 CFR 349.12, ophthalmic demulcents
- 21 CFR 349.14, ophthalmic emollients
- 21 CFR 349.10, ophthalmic astringent
- 21 CFR 349.20, eyewashes
- 21 CFR 886.4750, ophthalmic eye shield
- Medical Devices Regulations, SOR/98-282
- Health Canada, drug and health product portal
- Health Canada, lubricant eye drops and artificial tears record
- Health Canada, ALCON TEARS 1% record
- ISO 15004-1:2020, ophthalmic instruments
- ISO 18369-1:2017, ophthalmic optics vocabulary
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- American Academy of Ophthalmology, dry eye
- American Academy of Ophthalmology, pink eye
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- openFDA device classification API
A lubricant shelf with a gap in its record is the same shelf that gets a complaint. The downloadable eye room stock sheet is a free sheet with columns for the product, the lot, the opening date and the discarding date, so the after-opening life of a bottle is written down rather than remembered. The stock sheet generator built for a two-room practice sizes the sheet to the number of examination rooms a practice runs. No account and no sign-up are needed to open either one.
Where the route of a lubricant or the record expected for a device needs to be set out for a records review, a written answer is worth more than a general one. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Eye Drops in Canada vs the US: Which Route Applies
- Eye Masks in Canada vs the US: Warm Compress for Dry Eye
- Heated Eye Mask Care and Storage Checklist for Canadian Clinics
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the choice of a lubricant and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Are artificial tears a drug in Canada?
Yes. A lubricant eye drop is authorised as a drug with a Drug Identification Number, and a Health Canada record describes the category as lubricant eye drops and artificial tears.
Can a lubricant eye drop be sold without a prescription in the United States?
A lubricant that matches the demulcent or emollient monograph in 21 CFR 349 can be sold without a prescription, because it enters the market under the category rather than under a product approval.
What is the difference between a demulcent and an emollient?
A demulcent attracts and holds water on the eye, and the monograph lists cellulose derivatives, polyols, polyvinyl alcohol and povidone. An emollient is an oily agent that slows evaporation, and the monograph lists light mineral oil, petrolatum and the waxes.
Why does a warm compress sit beside a lubricant?
An evaporative dry eye is a lid-margin problem, and warmth applied to the closed lid is the measure that helps a blocked meibomian gland. The compress is a device and the drop is a drug, so the two take different routes.
Does a preservative-free drop need different handling?
Yes. A preservative-free unit dose has a shorter after-opening life than a preserved bottle, so the opening date and the discarding date need their own columns on the stock sheet.
Which standard covers the ophthalmic instruments used alongside these drops?
ISO 15004-1:2020 covers the general requirements for ophthalmic instruments, and ISO 18369-1:2017 carries the optics vocabulary.
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