FDA.reportPublic FDA data

SK Original Eye Drops

Manufacturer
Synpac-Kingdom Pharmaceuticals, Co., Ltd.
Effective date
2021-06-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:42:36

Label at a glance#

ProductSK Original Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Tetrahydrozoline HCl 0.05%

OTC - PURPOSE SECTION

Purpose

Tetrahydrozoline HCl......Redness reliever

INDICATIONS & USAGE SECTION

Use

  • for the relief of redness of the eye due to minor eye irritations

WARNINGS SECTION

Warnings

For external use only

Do not use if solution changes color or becomes cloudy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma

OTC - WHEN USING SECTION

When using this product

  • pupils may become enlarged temporarily
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after using
  • overuse may produce increased redness of the eye

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • coontinued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature
  • Remove contact lens before using

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130381772001014GTIN-13: 0381772001014
EAN-13: 0381772001014
GTIN-12: 381772001014
UPC-A: 381772001014
GTIN storage (14 digits): 00381772001014		01-SK Original Eye Drops.jpg

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
81772-00181772-001-01

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
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
SODIUM BORATE91MBZ8H3QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
WATER059QF0KO0RIACT

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
41e8d38d-f4be-47a4-9262-401ba6573594bb69ccea-0010-43d6-99e1-28370a77751d2022-10-31WarningsExact identifier
spl set id: bb69ccea-0010-43d6-99e1-28370a77751d

Reported adverse events (FAERS/openFDA)#

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