FDA Registration for OTC Ophthalmic Drug Products
OTC ophthalmic products (eye drops, eye washes, eye lubricants) are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.
FDA Requirements for OTC Ophthalmic Drug Products
OTC ophthalmic drug products include eye drops, eye washes, and lubricating eye solutions. These products are regulated as OTC drugs and must meet additional sterility and packaging requirements.
Permitted OTC ophthalmic active ingredients include tetrahydrozoline HCl (vasoconstrictor), naphazoline HCl, and various demulcents for dry eye relief.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Sterility testing and container requirements
- Annual renewal October 1–December 31
The FDA has an OTC monograph that outlines the safety and efficacy standards for certain eye drops and eye care products sold over-the-counter. This means that manufacturers can follow this guideline to create products without needing individual FDA approval, as long as they stick to specific ingredients, concentrations, and labeling. The monograph covers six categories of ophthalmic drugs, including lubricants for dry eyes, mild astringents, and redness relievers. Essentially, it ensures a baseline level of safety and effectiveness for these common eye care products.
M018.10 Ophthalmic astringent
| Active Ingredients | OTC Monograph Number |
|---|---|
| Zinc sulfate, 0.25 percent | M018.10 (Part 349) |
M018.12 Ophthalmic demulcents
| Active Ingredients | OTC Monograph Number |
|---|---|
| (a) Cellulose derivatives: | |
| (1) Carboxymethylcellulose sodium, 0.2 to 2.5 percent | M018.12 (Part 349) |
| (2) Hydroxyethyl cellulose, 0.2 to 2.5 percent | M018.12 (Part 349) |
| (3) Hypromellose, 0.2 to 2.5 percent | M018.12 (Part 349) |
| (4) Methylcellulose, 0.2 to 2.5 percent | M018.12 (Part 349) |
| (b) Dextran 70, 0.1 percent when used with another polymeric demulcent agent in § M018.12 | M018.12 (Part 349) |
| (c) Gelatin, 0.01 percent. | M018.12 (Part 349) |
| (d) Polyols, liquid | |
| (1) Glycerin, 0.2 to 1 percent | M018.12 (Part 349) |
| (2) Polyethylene glycol 300, 0.2 to 1 percent | M018.12 (Part 349) |
| (3) Polyethylene glycol 400, 0.2 to 1 percent | M018.12 (Part 349) |
| (4) Polysorbate 80, 0.2 to 1 percent | M018.12 (Part 349) |
| (5) Propylene glycol, 0.2 to 1 percent | M018.12 (Part 349) |
| (e) Polyvinyl alcohol, 0.1 to 4 percent | M018.12 (Part 349) |
| (f) Povidone, 0.1 to 2 percent | M018.12 (Part 349) |
M018.14 Ophthalmic emollients
| Active Ingredients | OTC Monograph Number |
|---|---|
| (a) Lanolin preparations: | |
| (1) Anhydrous lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the OTC monograph. | M018.14 (Part 349) |
| (2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the OTC monograph. | M018.14 (Part 349) |
| (b) Oleaginous ingredients: | |
| (1) Light mineral oil, up to 50 percent, in combination with one or more other emollient agents | M018.14 (Part 349) |
| (2) Mineral oil, up to 50 percent, in combination with one or more other emollient agents | M018.14 (Part 349) |
| (3) Paraffin, up to 5 percent, in combination with one or more other emollient agents included in the OTC monograph. | M018.14 (Part 349) |
| (4) Petrolatum, up to 100 percent | M018.14 (Part 349) |
| (5) White ointment, up to 100 percent. | M018.14 (Part 349) |
| (6) White petrolatum, up to 100 percent. | M018.14 (Part 349) |
| (7) White wax, up to 5 percent, in combination with one or more other emollient agents included in the OTC monograph. | M018.14 (Part 349) |
| (8) Yellow wax, up to 5 percent, in combination with one or more other emollient agents included in the OTC monograph. | M018.14 (Part 349) |
M018.16 Ophthalmic hypertonicity agent
| Active Ingredients | OTC Monograph Number |
|---|---|
| Sodium chloride, 2 to 5 percent | M018.16 (Part 349) |
M018.18 Ophthalmic vasoconstrictors
| Active Ingredients | OTC Monograph Number |
|---|---|
| (a) Ephedrine hydrochloride, 0.123 percent | M018.18 (Part 349) |
| (b) Naphazoline hydrochloride, 0.01 to 0.03 percent | M018.18 (Part 349) |
| (c) Phenylephrine hydrochloride, 0.08 to 0.2 percent | M018.18 (Part 349) |
| (d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent | M018.18 (Part 349) |
M018.20 Eyewashes
| Active Ingredients | OTC Monograph Number |
|---|---|
| Purified water | M018.20 (Part 349) |
M018.22 Emergency first aid eyewashes
| Active Ingredients | OTC Monograph Number |
|---|---|
| Water, agents to achieve the pH within a range of 6.6 and 7.4, and a suitable antimicrobial preservative agent | M018.22 (Part 349) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
OTC Ophthalmic Drug Products — FAQs
Are OTC eye drops regulated as drugs?
Do OTC eye products have special packaging requirements?
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