Quick facts
- United States: an eye ointment sold without a prescription sits in the ophthalmic emollient monograph at 21 CFR 349.14, which lists light mineral oil up to 50 percent and white petrolatum up to 100 percent.
- United States: the emollient monograph requires most of the oily agents to be used in combination with another agent in the monograph rather than alone.
- United States: the four ophthalmic monograph categories are the astringent at 21 CFR 349.10, the demulcent at 21 CFR 349.12, the emollient at 349.14 and the eyewash at 21 CFR 349.20.
- Canada: an ophthalmic ointment is authorised as a drug and carries a Drug Identification Number; the record for the product is what the shelf is checked against.
- Both countries: an ointment sits on the lid margin and stays put, which is why it is stocked beside a warm compress for lid-margin care rather than instead of a drop.
- Canada: the regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
An ointment on the lid margin looks the same in both countries, but the two systems behind it do not work the same way. On one side the product 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 is an ophthalmic ointment and where does it sit?
An ophthalmic ointment is a semi-solid product applied to the lid margin or into the lower lid, and it is used where a drop runs off the eye too quickly to keep a surface coated.
The two jobs an ointment is bought for are lubrication and lid-margin care. A lubricating ointment is an emollient, which means it slows the loss of water from the tear film rather than drawing water to the surface. A lid-margin ointment is applied to the base of the lashes, where a blocked oil gland is the problem, and it is used with warmth so the gland can clear. That is why a warm compress is stocked beside the ointment rather than instead of it.
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. A buyer reading a shelf against that distinction is really asking whether the room needs a demulcent, an emollient, or both.
| Product type | Monograph section | Action | Ingredient example |
|---|---|---|---|
| Astringent | 21 CFR 349.10 | Tightens surface tissue | A zinc salt |
| 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 |
| Eyewash | 21 CFR 349.20 | Flushes the surface | A buffered saline |
Are ophthalmic ointments 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 ophthalmic ointment is a drug, and it reaches the market through an authorisation that assigns it a Drug Identification Number. The number is the product's own, and a buyer checking a tube against a shelf label is checking it against that authorisation. The scope of the ophthalmic instrument standards that sit beside these products is carried in ISO 15004-1:2020.
In the United States an ointment 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 reformulates. 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.
| Item | Canada | United States |
|---|---|---|
| Route for an ointment | Drug authorisation with a Drug Identification Number | OTC ophthalmic monograph |
| Governing list | The product's own authorisation | 21 CFR 349.14, and 349.10 to 349.20 |
| What a reformulation touches | The product authorisation | The monograph conditions |
| Record a buyer can look up | The product record | The monograph section text |
How does the American monograph treat an ophthalmic emollient?
It lists the oily agents and their limits, and it requires most of them to be paired rather than used alone.
The emollient category in 21 CFR 349.14 covers light mineral oil, mineral oil, paraffin, petrolatum, white ointment, white petrolatum and the waxes. Light mineral oil is listed up to 50 percent and white petrolatum up to 100 percent. The section then sets a condition that matters on the shelf: most of the oily agents must be combined with another agent in the monograph rather than dispensed as the only active ingredient.
That requirement is the reason a single-ingredient petrolatum product and a combined oily product can both be lawfully sold while only the second is a complete emollient under the monograph. A buyer who orders by active ingredient alone can miss the pairing condition, which is a labelling requirement rather than a clinical one.
For the demulcent side, the same section family sets a concentration range for each active ingredient — 21 CFR 349.12 puts carboxymethylcellulose sodium and hypromellose at 0.2 to 2.5 percent, polyvinyl alcohol at 0.1 to 4 percent, and povidone at 0.1 to 2 percent. Those ranges are the reason two bottles with the same active ingredient can feel different.
How does the route differ between Canada and the United States for a reformulation?
The American route follows the category; the Canadian route follows the product. A reformulation that stays inside the American monograph is a labelling matter, while on the Canadian side the product's own authorisation is the document that has to be lined up.
The practical reading for a clinic is that a substitute is easier to defend in the United States than in Canada. An American buyer can check a new tube against the monograph section text and see whether the active ingredient and its range still match. A Canadian buyer has to check the new product against its own Drug Identification Number and the record behind it, because the authorisation is what carries the claim.
This is why the shelf record differs. An American shelf built around the monograph can group several products under one section reference. A Canadian shelf has to carry the product number for each line, because the number is what makes the product the same product when a supplier changes the base.
Do the United States and Canada treat an eye ointment the same way on the shelf?
No, and the difference shows up in what a stock sheet has to record. A Canadian shelf that carries the Drug Identification Number for each ointment can answer a substitution question without opening the tube; an American shelf that carries only a trade name cannot.
The record that closes the gap is the same on both sides — the product, the lot, the opening date and the discarding date on one sheet. What changes is the field that identifies the product: a drug number on the Canadian side and the monograph section on the American side. A sheet with both fields is the one that travels across a group of clinics without having to be rebuilt.
Which consumables does a lid care shelf restock?
A lid care shelf runs on the same consumables as the rest of the practice, and the two closest to the ointment are the swab and the paper. The double-tipped cotton swabs handle the lid margin clean before an ointment is applied, and the exam table paper is changed between patients. A practice that also runs its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-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.
Sources
- 21 CFR 349.10, ophthalmic astringent
- 21 CFR 349.12, ophthalmic demulcents
- 21 CFR 349.14, ophthalmic emollients
- 21 CFR 349.20, eyewashes
- 21 CFR 886.1120, ophthalmic camera
- 21 CFR 886.4750, ophthalmic eye shield
- Medical Devices Regulations, SOR/98-282
- ISO 15004-1:2020, ophthalmic instruments
- IEC 61010-1:2010, safety of electrical measuring equipment
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- openFDA device classification API
- American Academy of Ophthalmology, dry eye
- American Academy of Ophthalmology, pink eye
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- CCOHS, OSH answers
- Public Health Ontario, laboratory services test index
- CLSI, clinical and laboratory standards
- Ad Standards, non-prescription and cosmetic guidelines
An ointment shelf with a gap in its record is the same shelf that gets a substitution complaint. The printable ophthalmic ointment handling sheet is a free sheet with columns for the product, the drug number, the lot, the opening date and the discarding date, so the life of an opened tube is written down rather than remembered. The handling sheet generator built for a single 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.
Ordering ophthalmic supplies across several locations? See the wholesale ordering page.
Related reading
- Artificial Tears in Canada vs the US: Which Lubricant Rules Apply
- Conjunctivitis Eye Drops in Canada vs the US: Which Rules
- Eye Drops in Canada vs the US: Which Route Applies
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 an ointment and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Is an ophthalmic ointment a drug in Canada?
Yes. An ophthalmic ointment is authorised as a drug with a Drug Identification Number, and the product's own authorisation is what a shelf label and a substitution check are read against.
Can an ophthalmic ointment be sold without a prescription in the United States?
An ointment that matches the ophthalmic emollient monograph in 21 CFR 349.14 can be sold without a prescription, because it enters the market under the category rather than under a product approval.
What does the emollient monograph list as active ingredients?
It lists light mineral oil, mineral oil, paraffin, petrolatum, white ointment, white petrolatum and the waxes, with light mineral oil up to 50 percent and white petrolatum up to 100 percent.
Why must an oily agent be combined with another agent?
The emollient monograph requires most of the oily agents to be used together with another agent in the monograph rather than alone. A single oily agent on its own is not a complete emollient under the section.
Why does a warm compress sit beside an ointment?
A lid-margin problem is an oil gland problem, and warmth applied to the closed lid is the measure that helps a blocked gland clear. The compress is a device and the ointment is a drug, so the two take different routes.
Does a reformulation change the product in both countries?
In the United States a change that stays inside the monograph concentrations is handled as a labelling matter. In Canada the product's own authorisation is what governs, so the change is read against the Drug Identification Number.
0 comments