FDA.reportPublic FDA data

Tetrahydrozoline Ophthalmic Solution

Manufacturer
K.C. Pharmaceuticals, Inc.
Effective date
2019-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:20:58

Label at a glance#

ProductTetrahydrozoline Ophthalmic Solution
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCI 0.05%

Purpose

OTC - PURPOSE SECTION

Redness Reliever

Use

INDICATIONS & USAGE SECTION

relieves redness in eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

Warnings

OTC - WHEN USING SECTION

When using this product

  • 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

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help, or contact Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

instill 1 to 2 drops in the affected eye(s) up to 4 times daily

Other Information

OTHER SAFETY INFORMATION

store at 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Rugby Tetrahydrozoline Ophthalmic Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Tetrahydrozoline Ophthalmic SolutionRugby Tetrahydrozoline Ophthalmic Solution

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55651-12155651-121-94

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM BORATE91MBZ8H3QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8b52b564-3496-45a3-e053-2995a90a9c6e8b52b564-3495-45a3-e053-2995a90a9c6e2019-06-14WarningsExact identifier
spl id: 8b52b564-3496-45a3-e053-2995a90a9c6e
spl set id: 8b52b564-3495-45a3-e053-2995a90a9c6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.