21 C.F.R. § 349.20 Eyewashes.
Title 21 - Food and Drugs
The active ingredient of the product is purified water. The product also contains suitable tonicity agents to establish isotonicity with tears, suitable agents for establishing pH and buffering to achieve the same pH as tears, and a suitable preservative agent. [68 FR 7921, Feb. 19, 2003]
Title 21: Food and Drugs
PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 349.20 Eyewashes.