Ophthalmic Products

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 percentM018.10 (Part 349)

M018.12 Ophthalmic demulcents

Active Ingredients OTC Monograph Number
(a) Cellulose derivatives:
(1) Carboxymethylcellulose sodium, 0.2 to 2.5 percentM018.12 (Part 349)
(2) Hydroxyethyl cellulose, 0.2 to 2.5 percentM018.12 (Part 349)
(3) Hypromellose, 0.2 to 2.5 percentM018.12 (Part 349)
(4) Methylcellulose, 0.2 to 2.5 percentM018.12 (Part 349)
(b) Dextran 70, 0.1 percent when used with another polymeric demulcent agent in ยง M018.12M018.12 (Part 349)
(c) Gelatin, 0.01 percent.M018.12 (Part 349)
(d) Polyols, liquid
(1) Glycerin, 0.2 to 1 percentM018.12 (Part 349)
(2) Polyethylene glycol 300, 0.2 to 1 percentM018.12 (Part 349)
(3) Polyethylene glycol 400, 0.2 to 1 percentM018.12 (Part 349)
(4) Polysorbate 80, 0.2 to 1 percentM018.12 (Part 349)
(5) Propylene glycol, 0.2 to 1 percentM018.12 (Part 349)
(e) Polyvinyl alcohol, 0.1 to 4 percentM018.12 (Part 349)
(f) Povidone, 0.1 to 2 percentM018.12 (Part 349)

M018.14 Ophthalmic emollients

Active Ingredients OTC Monograph Number
(a) Lanolin preparations:
(1) Anhydrous lanolin, 1 to 10 percentM018.14 (Part 349)
(2) Lanolin, 1 to 10 percentM018.14 (Part 349)
(b) Oleaginous ingredients:
(1) Light mineral oil, up to 50 percent, in combination with one or more other emollient agentsM018.14 (Part 349)
(2) Mineral oil, up to 50 percent, in combination with one or more other emollient agentsM018.14 (Part 349)
(3) Paraffin, up to 5 percent, in combination with one or moreM018.14 (Part 349)
(4) Petrolatum, up to 100 percentM018.14 (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 percentM018.16 (Part 349)

M018.18 Ophthalmic vasoconstrictors

Active Ingredients OTC Monograph Number
(a) Ephedrine hydrochloride, 0.123 percentM018.18 (Part 349)
(b) Naphazoline hydrochloride, 0.01 to 0.03 percentM018.18 (Part 349)
(c) Phenylephrine hydrochloride, 0.08 to 0.2 percentM018.18 (Part 349)
(d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percentM018.18 (Part 349)

M018.20 Eyewashes

Active Ingredients OTC Monograph Number
Purified waterM018.20 (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 agentM018.22 (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.

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