Winco Irritation Relief (pld)

SPL v5

SPL

SPL Set ID 60565184-5745-43a5-92b2-ab45b27e8bc6

Route

OPHTHALMIC

Published

Effective Date 2015-02-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tetrahydrozoline (50 mg) Zinc Cation (250 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Chloride Sodium Citrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-01-09

Description

Active ingredients Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

for temporary relief of discomfort and redness of the eye due to minor eye irritations

Dosage and Administration

Directions

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

Description

Active ingredients Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Section 42228-7

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

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 becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6

Inactive ingredients

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

Section 51945-4

Section 55105-1

Purpose

Tetrahydrozoline HCl...Redness Reliever

Zinc sulfate...Astringent

Section 55106-9

Active ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Section 60561-8

Other information

Store at 15°-30°C (59°-86°F)

Structured Label Content

Indications and Usage (34067-9)

Uses

for temporary relief of discomfort and redness of the eye due to minor eye irritations

Dosage and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42228-7 (42228-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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

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 becomes cloudy, do not use
overuse may produce increased redness of the eye
remove contact lens before using

Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Tetrahydrozoline HCl...Redness Reliever

Zinc sulfate...Astringent

Section 55106-9 (55106-9)

Active ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Section 60561-8 (60561-8)

Other information

Store at 15°-30°C (59°-86°F)

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "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 CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "250", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for temporary relief of discomfort and redness of the eye due to minor eye irritations", "34068-7": "Directions Instill 1 or 2 drops in the affected eye(s) up to four times daily.", "34071-1": "Warnings For external use only", "42228-7": "If pregnant or breast-feeding , ask a health professional before use.", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center 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 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 becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using", "50569-3": "Ask a doctor before use if you have narrow angle glaucoma", "51727-6": "Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium citrate", "55105-1": "Purpose Tetrahydrozoline HCl...Redness Reliever Zinc sulfate...Astringent", "55106-9": "Active ingredients Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%", "60561-8": "Other information Store at 15°-30°C (59°-86°F)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:00.542574 · Updated: 2026-03-14T23:12:08.624404