0498-0161: Eye Drops

0498-0161: Eye Drops
SPL v10
SPL
SPL Set ID 703645d0-5157-7a83-e053-2a91aa0a903e
Route
OPHTHALMIC
Published
Effective Date 2018-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tetrahydrozoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Boric Acid Edetate Disodium Water Sodium Borate Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-04
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

relieves 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

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information S tore at 15° to 30°C (59° to 86°F)

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
  • the condition worsens or persists for more than 72 hours
Section 50567-7

When using this product

  • pupils may become enlarged temporarily
  • overuse may produce increased redness of the eye
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 50569-3

Ask a doctor before use if you have narrow angle glaucoma

Section 50570-1

Do not use if solution changes color or becomes cloudy

Section 51727-6

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Redness reliever

Section 55106-9

Active ingredient

Tetrahydrozoline HCl 0.05%

Structured Label Content

Indications and Usage (34067-9)

Uses

relieves 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 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information S tore at 15° to 30°C (59° to 86°F)

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
  • the condition worsens or persists for more than 72 hours
Section 50567-7 (50567-7)

When using this product

  • pupils may become enlarged temporarily
  • overuse may produce increased redness of the eye
  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
Section 50569-3 (50569-3)

Ask a doctor before use if you have narrow angle glaucoma

Section 50570-1 (50570-1)

Do not use if solution changes color or becomes cloudy

Section 51727-6 (51727-6)

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Redness reliever

Section 55106-9 (55106-9)

Active ingredient

Tetrahydrozoline HCl 0.05%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.522289 · Updated: 2026-03-14T23:02:25.522673