Sunmark Dry Eye Relief (pld)

SPL v3

SPL

SPL Set ID 043ccc34-44ee-416a-88bc-f247774e9075

Route

OPHTHALMIC

Published

Effective Date 2017-02-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-05-01

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
Children under 6 years of age: ask doctor

Description

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

Section 50565-1

Keep out of reach of children

If accidentally swallowed get medical help or contact a Poison Control Center immediately

Section 50567-7

When using this product

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

Section 50569-3

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 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 53414-9

If pregnant and 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

RETAIN THIS CARTON FOR FUTURE REFERENCE

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

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
Children under 6 years of age: ask doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If accidentally swallowed get medical help or contact a Poison Control Center immediately

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. Keep container tightly closed
remove contact lens before using

Section 50569-3 (50569-3)

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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant and 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

RETAIN THIS CARTON FOR FUTURE REFERENCE

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

Advanced Ingredient Data

[{"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CHLORIDE", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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 Children under 6 years of age: ask doctor", "34071-1": "Warnings For external use only", "50565-1": "Keep out of reach of children If accidentally swallowed get medical help or contact a Poison Control Center immediately", "50567-7": "When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed remove contact lens before using", "50569-3": "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", "50570-1": "Do not use this product if solution changes color or becomes cloudy", "51727-6": "Inactive ingredients dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water", "53414-9": "If pregnant and 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 RETAIN THIS CARTON FOR FUTURE REFERENCE Store at 15 o C-30 o C (59 o -86 o F)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:38.843466 · Updated: 2026-03-14T23:02:19.584479