Drug Facts

SPL v6

SPL

SPL Set ID 5d6f37b9-b568-4cb6-92de-eb40779f3f8c

Route

OPHTHALMIC

Published

Effective Date 2018-01-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Hypromellose, Unspecified (3.5 mg) Tetrahydrozoline (0.5 mg)

Inactive Ingredients

Benzalkonium Chloride Boric Acid Chlorobutanol Cyanocobalamin Edetate Disodium Menthol, Unspecified Form Polysorbate 80 Potassium Aspartate Water Pyridoxine Hydrochloride Sodium Borate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Hypromellose 0.35% Tetrahydrozoline hydrochloride 0.05%

Purpose

Hypromellose - Lubricant Tetrahydrozoline hydrochloride - Redness reliever

Medication Information

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

Description

Hypromellose 0.35% Tetrahydrozoline hydrochloride 0.05%

Uses

temporarily relieves burning and irritation due to dryness of the eye
relieves redness of the eye due to minor eye irritations

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

store at 20-25°C (68-77°F)

Active Ingredients

Hypromellose 0.35%

Tetrahydrozoline hydrochloride 0.05%

Inactive Ingredients

benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

Questions Or Comments?

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

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

temporarily relieves burning and irritation due to dryness of the eye
relieves redness of the eye due to minor eye irritations

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

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

store at 20-25°C (68-77°F)

Active Ingredients (Active ingredients)

Hypromellose 0.35%

Tetrahydrozoline hydrochloride 0.05%

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

Questions Or Comments? (Questions or comments?)

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

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": "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": "CYANOCOBALAMIN", "unii": "P6YC3EG204", "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": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "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": "PYRIDOXINE HYDROCHLORIDE", "unii": "68Y4CF58BV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BORATE", "unii": "91MBZ8H3QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves burning and irritation due to dryness of the eye relieves redness of the eye due to minor eye irritations", "Purpose": "Hypromellose - Lubricant Tetrahydrozoline hydrochloride - Redness reliever", "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 store at 20-25°C (68-77°F)", "Active ingredients": "Hypromellose 0.35% Tetrahydrozoline hydrochloride 0.05%", "Inactive ingredients": "benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate", "Questions or comments?": "1-877-636-2677 MON-FRI 9AM to 5PM (EST)", "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: 2026-02-15T12:04:51.966294 · Updated: 2026-03-14T23:05:57.575147