SPL v6
SPL
SPL Set ID aec2ef95-0b9b-48dd-8809-73d19e309e4f
Route
OPHTHALMIC
Published
Effective Date 2022-05-27
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 2019-02-19
Description

Tetrahydrozoline HCL 0.05%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • relieves redness of the eye due to minor eye irritations
Dosage and Administration

Instill 1 or 2 drops in the affected eye(s) up to four times daily

Description

Tetrahydrozoline HCL 0.05%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
Section 50567-7
  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using
Section 50569-3

narrow angle glaucoma

Section 51727-6

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

Section 51945-4

Section 53413-1

1-888-527-4276

Section 53414-9

ask a health professional before use

Section 55105-1

Redness reliever

Section 55106-9

Tetrahydrozoline HCL 0.05%

Section 60561-8

store at 15-30°C (59°-86°F)

Structured Label Content

Indications and Usage (34067-9)
  • relieves redness of the eye due to minor eye irritations
Dosage and Administration (34068-7)

Instill 1 or 2 drops in the affected eye(s) up to four times daily

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
Section 50567-7 (50567-7)
  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using
Section 50569-3 (50569-3)

narrow angle glaucoma

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-888-527-4276

Section 53414-9 (53414-9)

ask a health professional before use

Section 55105-1 (55105-1)

Redness reliever

Section 55106-9 (55106-9)

Tetrahydrozoline HCL 0.05%

Section 60561-8 (60561-8)

store at 15-30°C (59°-86°F)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.170584 · Updated: 2026-03-06T01:18:43.999857