Leader Artificial Tears 15 mL

Polyvinyl Alcohol, Povidone · Solution/ Drops · Ophthalmic

Over the counter 1 recall

Active ingredient

Active Ingredients Polyvinyl alcohol 0.5% Povidone 0.6%

Purpose

Purposes Lubricant Lubricant

Uses

Uses for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lens before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children. if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

Do not use

Do not use this product if solution changes color or becomes cloudy

When using this product

When using this product remove contact lens before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed.

Stop use and ask a doctor

Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Keep out of reach of children

Keep out of the reach of children. if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

Directions

Directions instill 1 or 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor

Inactive ingredients

Inactive Ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

Questions or comments? Call 1-888-527-4276

Label text from the FDA structured product label by Cardinal Health (revised Sep 9, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Leader Artificial Tears 15 mL NDC products (1)

NDCStrength & formLabelerType
70000-0011Polyvinyl Alcohol, Unspecified .5 g/100mL; Povidone .6 g/100mL
Solution/ Drops
Cardinal HealthOTC MONOGRAPH DRUG

Leader Artificial Tears 15 mL recalls

Frequently asked questions

What is Leader Artificial Tears 15 mL used for?

Uses for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Who makes Leader Artificial Tears 15 mL?

Leader Artificial Tears 15 mL is listed by 1 labeler in the FDA NDC directory, including Cardinal Health.

Has Leader Artificial Tears 15 mL been recalled?

The FDA enforcement database lists 1 recall for Leader Artificial Tears 15 mL, most recently D-0416-2026 (class ii): Lack of Assurance of Sterility