Leader Lubricant Eye Drops Long Lasting (pld)

SPL v6

SPL

SPL Set ID 0a7c0f59-dd38-4dba-bd04-af1ec75d6569

Route

OPHTHALMIC

Published

Effective Date 2021-06-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polyethylene Glycol 400 (0.4 g) Propylene Glycol (0.3 g)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Calcium Chloride Hypromelloses Magnesium Chloride Potassium Chloride Water Sodium Borate Sodium Chloride Zinc Chloride

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-02-19 Until 2025-07-31

Description

Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

Dosage and Administration

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed

• Children under 6 years of age: ask a doctor

Description

Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9

Stop use and ask a doctor if

• you feel eye pain

• changes in vision occur

• redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Section 50567-7

When using this product

• do not touch the tip of container to any surface to avoid contamination

• replace cap after each use

Section 50570-1

Do not use

• if this product changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

Section 51727-6

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

Section 51945-4

Section 55105-1

Purpose

Polyethylene glycol 400............. Lubricant

Propylene glycol............ Lubricant

Section 55106-9

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Section 60561-8

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

Dosage and Administration (34068-7)

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed

• Children under 6 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• you feel eye pain

• changes in vision occur

• redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Section 50567-7 (50567-7)

When using this product

• do not touch the tip of container to any surface to avoid contamination

• replace cap after each use

Section 50570-1 (50570-1)

Do not use

• if this product changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

Section 51727-6 (51727-6)

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Polyethylene glycol 400............. Lubricant

Propylene glycol............ Lubricant

Section 55106-9 (55106-9)

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Section 60561-8 (60561-8)

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at room temperature

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses • for the temporary relief of burning and irritation due to dryness of the eye", "34068-7": "Directions • Instill 1 or 2 drops in the affected eye(s) as needed • Children under 6 years of age: ask a doctor", "34071-1": "Warnings For external use only", "50565-1": "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away", "50566-9": "Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye(s) gets worse or lasts more than 72 hours", "50567-7": "When using this product • do not touch the tip of container to any surface to avoid contamination • replace cap after each use", "50570-1": "Do not use • if this product changes color or becomes cloudy • if you are sensitive to any ingredient in this product", "51727-6": "Inactive ingredients Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.", "55105-1": "Purpose Polyethylene glycol 400............. Lubricant Propylene glycol............ Lubricant", "55106-9": "Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%", "60561-8": "Other information RETAIN THIS CARTON FOR FUTURE REFERENCE Store at room temperature"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.729826 · Updated: 2026-03-06T01:24:07.160722