Leader Dry Eye Relief Eye Drops (pld)

SPL v6

SPL

SPL Set ID 2ded4bda-b3c3-4521-8701-5c8446fd148b

Route

OPHTHALMIC

Published

Effective Date 2022-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Glycerin (0.2 g) Hypromellose, Unspecified (1 g) Polyethylene Glycol 400

Inactive Ingredients

Benzalkonium Chloride Dextrose Edetate Disodium Potassium Chloride Water Sodium Bicarbonate Sodium Chloride Sodium Citrate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-30 Until 2025-07-31

Description

Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 1%

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
for protection against further irritation

Dosage and Administration

Directions

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

Description

Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 1%

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 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

Section 50567-7

When using this product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
remove contact lens before using

Section 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

Section 55106-9

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

Section 60561-8

Other information

Store at 15 ^o-30 ^oC (59 ^o-86 ^oF)

Directions

Sequence 5

Leader Dry Eye Relief Eye Drops 15ml

Leader Dry Eye Relief Eye Drops 15ml Twin Pk

Structured Label Content

Indications and Usage (34067-9)

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for protection against further irritation

Dosage and Administration (34068-7)

Directions

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

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 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

Section 50567-7 (50567-7)

When using this product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
remove contact lens before using

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Glycerin.....Lubricant

Hypromellose.....Lubricant

Polyethylene glycol 400.....Lubricant

Section 55106-9 (55106-9)

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 1%

Section 60561-8 (60561-8)

Other information

Store at 15 ^o-30 ^oC (59 ^o-86 ^oF)

Directions

Sequence 5

Leader Dry Eye Relief Eye Drops 15ml (Leader Dry Eye Relief Eye Drops 15mL)

Leader Dry Eye Relief Eye Drops 15ml Twin Pk (Leader Dry Eye Relief Eye Drops 15mL twin pk)

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "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 BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "1", "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 for protection against further irritation", "34068-7": "Directions Instill 1 or 2 drops in the affected eye(s) as needed", "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 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", "50567-7": "When using this product to avoid contamination, do not touch tip of container to any surface. Replace cap after using. remove contact lens before using", "50570-1": "Do not use this product if solution changes color or becomes cloudy", "51727-6": "Inactive ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic ", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Glycerin.....Lubricant Hypromellose.....Lubricant Polyethylene glycol 400.....Lubricant", "55106-9": "Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 1%", "60561-8": "Other information Store at 15 o -30 o C (59 o -86 o F)", "Directions": "Sequence 5"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:40.739827 · Updated: 2026-03-14T23:09:34.496634