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OTC products · Product label record

Leader Artificial Tears 15 mL drug information

POLYVINYL ALCOHOL, POVIDONE
Cardinal Health · OPHTHALMIC

Product NDC: 70000-0011

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic namePOLYVINYL ALCOHOL, POVIDONE
Labeler / manufacturerCardinal Health
RouteOPHTHALMIC
Drug classDrug class not supplied in source label
Product NDC70000-0011
Label effective date2026-09-09

Official product label reference

Leader Artificial Tears 15 mL — Cardinal Health

This page contains 12 source sections for POLYVINYL ALCOHOL, POVIDONE, ophthalmic route. Label set 8cccc589-3a8e-baad-e053-2a95a90ab8c7, version 6.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purposes Lubricant Lubricant
Dosage and administration — label text
Directions instill 1 or 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor
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.
Active ingredient
Active Ingredients Polyvinyl alcohol 0.5% Povidone 0.6%
Do not use
Do not use this product if solution changes color or becomes cloudy
While using this medicine
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.
When to stop use and seek help
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
Child safety
Keep out of the reach of children. if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.
Other safety information
Other Information store at 15°-30°C (59°-86°F)
Inactive ingredient
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

Official sources and product identifiers

Substances listed: POLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE

RxNorm identifiers: 598050

Package NDC codes

70000-0011-1

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.