Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID e4b49550-1ca3-4bd7-854d-409b53fa5e26

Route

OPHTHALMIC

Published

Effective Date 2021-07-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Naphazoline (1 mg) Polysorbate 80 (0.3 mg)

Inactive Ingredients

Alcohol Benzalkonium Chloride Boric Acid Chlorobutanol Edetate Disodium Menthol, Unspecified Form Potassium Aspartate Water Sodium Borate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-05-12

Description

Naphazoline hydrochloride 0.03% Polysorbate 80 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever Polysorbate 80 - Lubricant

Medication Information

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Description

Naphazoline hydrochloride 0.03% Polysorbate 80 0.2%

Uses

relieves redness of the eye due to minor eye irritations
temporarily relieves burning and irritation due to dryness of the eye
for protection against further irritation

Warnings

For external use only

Directions

put 1 or 2 drops in the affected eye(s) up to 4 times daily
tightly snap on cap to seal

Other information

do not store above 25°C (77°F)

Questions?

1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)

Active Ingredients

Naphazoline hydrochloride 0.03%

Polysorbate 80 0.2%

Inactive Ingredients

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water, sodium borate

When Using This Product

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

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

narrow angle glaucoma

Package/label Principal Display Panel

Structured Label Content

Uses

relieves redness of the eye due to minor eye irritations
temporarily relieves burning and irritation due to dryness of the eye
for protection against further irritation

Purpose

Naphazoline hydrochloride - Redness reliever

Polysorbate 80 - Lubricant

Warnings

For external use only

Directions

put 1 or 2 drops in the affected eye(s) up to 4 times daily
tightly snap on cap to seal

Other information

do not store above 25°C (77°F)

Questions?

1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)

Active Ingredients (Active ingredients)

Naphazoline hydrochloride 0.03%

Polysorbate 80 0.2%

Inactive Ingredients (Inactive ingredients)

alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water, sodium borate

When Using This Product (When using this product)

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

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 eyes lasts
condition worsens or lasts more than 72 hours

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

If swallowed, get medical help or contact a Poison Control Center right away.

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

narrow angle glaucoma

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BORIC ACID", "unii": "R57ZHV85D4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLOROBUTANOL", "unii": "HM4YQM8WRC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM ASPARTATE", "unii": "OC4598NZEQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NAPHAZOLINE", "unii": "H231GF11BV", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves redness of the eye due to minor eye irritations temporarily relieves burning and irritation due to dryness of the eye for protection against further irritation", "Purpose": "Naphazoline hydrochloride - Redness reliever Polysorbate 80 - Lubricant", "Warnings": "For external use only", "Directions": "put 1 or 2 drops in the affected eye(s) up to 4 times daily tightly snap on cap to seal Other information do not store above 25°C (77°F)", "Questions?": "1-877-636-2677 MON-FRI 9 AM - 5 PM (EST)", "Active ingredients": "Naphazoline hydrochloride 0.03% Polysorbate 80 0.2%", "Inactive ingredients": "alcohol (0.1%), benzalkonium chloride, boric acid, chlorobutanol, edetate disodium, menthol, potassium aspartate, purified water, sodium borate", "When using this product": "do not touch tip of container to any surface to avoid contamination replace cap after each use do not use if solution changes color or becomes cloudy overuse may cause more eye redness pupils may become enlarged temporarily remove contact lenses before using", "Stop use and ask a doctor if": "you feel eye pain changes in vision occur redness or irritation of the eyes lasts condition worsens or lasts more than 72 hours", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "narrow angle glaucoma"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.722432 · Updated: 2026-03-14T23:05:59.331876