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

Active Ingredient

Active ingredient

Tetrahydrozoline HCl 0.05%

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

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Tetrahydrozoline HCl 0.05%

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.

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

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