leader ultra lubricating eye drops (pld)

SPL v8

SPL

SPL Set ID d7f011a2-05ba-47c3-9519-d31602e105c7

Route

ophthalmic

Published

Effective Date 2021-06-08

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 aminomethylpropanol boric acid hypromelloses potassium chloride water sodium chloride sorbitol

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2019-02-19 Until 2027-02-28

Description

Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

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

Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Section 51945-4

Section 55105-1

Purpose

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

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

Section 60561-8

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at room temperature

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

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

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

Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

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

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

Section 60561-8 (60561-8)

Other information

RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at room temperature

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CHLORIDE", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

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 Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol", "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: 2026-02-15T12:06:40.784638 · Updated: 2026-03-14T23:14:12.168159