Visine® A.c. Itchy Eye Relief

SPL v3

SPL

SPL Set ID 257b9666-0163-499b-9673-bf6f4d6899b1

Route

OPHTHALMIC

Published

Effective Date 2019-03-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tetrahydrozoline (0.5 mg) Zinc Cation (2.5 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Chloride Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-05-06

Description

Drug Facts

Medication Information

Description

Drug Facts

Use

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma.

Section 53414-9

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

Section 55105-1

Active ingredients	Purpose
Tetrahydrozoline HCl 0.05%	Redness reliever
Zinc sulfate 0.25%	Astringent

Warnings

For external use only

Directions

put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor
children under 2 years of age: do not use

Questions?

call toll-free 888-734-7648 or 215-273-8755 (collect)

Other Information

store at 15° to 25°C (59° to 77°F)

Inactive Ingredients

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

When Using This Product

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination
replace cap after each use
some users may experience a brief tingling sensation

Stop Use and Ask A Doctor If

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

Principal Display Panel 15 Ml Bottle Carton

VISINE _®

A.C.

ITCHY EYE RELIEF

ASTRINGENT /

REDNESS RELIEVER EYE DROPS

RELIEVES ITCHY, RED,

WATERY EYES

STERILE

1/2 FL OZ (15mL)

Structured Label Content

Use

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

Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredients	Purpose
Tetrahydrozoline HCl 0.05%	Redness reliever
Zinc sulfate 0.25%	Astringent

Warnings

For external use only

Directions

put 1 to 2 drops in the affected eye(s) up to 4 times daily
children under 6 years of age: ask a doctor
children under 2 years of age: do not use

Questions?

call toll-free 888-734-7648 or 215-273-8755 (collect)

Other Information (Other information)

store at 15° to 25°C (59° to 77°F)

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

pupils may become enlarged temporarily
overuse may cause more eye redness
remove contact lenses before using
do not use if this solution changes color or becomes cloudy
do not touch tip of container to any surface to avoid contamination
replace cap after each use
some users may experience a brief tingling sensation

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

Principal Display Panel 15 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton)

VISINE _®

A.C.

ITCHY EYE RELIEF

ASTRINGENT /

REDNESS RELIEVER EYE DROPS

RELIEVES ITCHY, RED,

WATERY EYES

STERILE

1/2 FL OZ (15mL)

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, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "for temporary relief of discomfort and redness of the eye due to minor eye irritations", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50569-3": "Ask a doctor before use if you have narrow angle glaucoma.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients Purpose Tetrahydrozoline HCl 0.05% Redness reliever Zinc sulfate 0.25% Astringent", "Warnings": "For external use only", "Directions": "put 1 to 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age: ask a doctor children under 2 years of age: do not use", "Questions?": "call toll-free 888-734-7648 or 215-273-8755 (collect)", "Other information": "store at 15° to 25°C (59° to 77°F)", "Inactive ingredients": "benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate", "When using this product": "pupils may become enlarged temporarily overuse may cause more eye redness remove contact lenses before using do not use if this solution changes color or becomes cloudy do not touch tip of container to any surface to avoid contamination replace cap after each use some users may experience a brief tingling sensation", "Stop use and ask a doctor if": "you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours", "PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton": "VISINE ® A.C. ITCHY EYE RELIEF ASTRINGENT / REDNESS RELIEVER EYE DROPS RELIEVES ITCHY, RED, WATERY EYES STERILE 1/2 FL OZ (15mL)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:23.922520 · Updated: 2026-03-14T23:05:05.669082