sunmark eye drops advanced moisturizer/lubricant (pld)

SPL v4

SPL

SPL Set ID 0daa4e39-0447-44b6-a7d7-370b12bf9451

Route

ophthalmic

Published

Effective Date 2016-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dextran 70 (0.1 g) polyethylene glycol 400 (1 g) povidone (0.05 g) tetrahydrozoline

Inactive Ingredients

benzalkonium chloride edetate disodium water sodium chloride sodium borate boric acid

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2007-03-01

Purpose

Eye Lubricant Redness reliever

Description

Dextran 70 0.1% povidone 1% Polyethylene glycol 400 1% Tetrahydrozoline HCL 0.05%

Medication Information

Warnings

For external use only

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

Purpose

Eye Lubricant

Redness reliever

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other Information

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

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Description

Dextran 70 0.1% povidone 1% Polyethylene glycol 400 1% Tetrahydrozoline HCL 0.05%

Section 51945-4

Active Ingredients

Dextran 70 0.1%

povidone 1%

Polyethylene glycol 400 1%

Tetrahydrozoline HCL 0.05%

When Using This Product

pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
if solution changes color or become cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

If Pregnant Or Breast Feeding

ask a healthcare professional before use

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

narrow angle glucoma

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

Structured Label Content

Warnings

For external use only

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

Purpose

Eye Lubricant

Redness reliever

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Other Information (Other information)

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

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Section 51945-4 (51945-4)

Active Ingredients

Dextran 70 0.1%

povidone 1%

Polyethylene glycol 400 1%

Tetrahydrozoline HCL 0.05%

When Using This Product (When using this product)

pupils may become enlarged temporarily
to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
if solution changes color or become cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a healthcare professional before use

Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

narrow angle glucoma

Stop Use and Ask A Doctor If You Experience (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

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "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": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTRAN 70", "unii": "7SA290YK68", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye", "Purpose": "Eye Lubricant Redness reliever", "Warnings": "For external use only", "Directions": "Instill 1 or 2 drops in the affected eye(s) up to four times daily.", "Other information": "Store at 15 o - 30 o C (59 o - 86 o F)", "Active Ingredients": "Dextran 70 0.1% povidone 1% Polyethylene glycol 400 1% Tetrahydrozoline HCL 0.05%", "Inactive Ingredients": "benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride", "When using this product": "pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or become cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using", "If pregnant or breast-feeding": "ask a healthcare professional before use", "Keep out of reach of children": "If accidentally swallowed, get medical help or contact a Poison Control Center immediately", "Ask a doctor before use if you have": "narrow angle glucoma", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.858799 · Updated: 2026-03-14T23:02:19.584479