Colirio Ocusan

Manufacturer: Samchundang Pharm. Co., Ltd.
Effective date: 2010-07-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:52:37

Label at a glance#

ProductColirio Ocusan

Active ingredientPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE

Label structure7 sections

Indications and uses

relieves redness of the eye due to minor eye irritations as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

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

Storage and handling

Store at 15 - 30C (59 - 86F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Polyethylene glycol 400 1%................Eye lubricant

Tetrahydrozoline HCl 0.05%..........Redness reliever

Uses

INDICATIONS & USAGE SECTION

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

WARNINGS SECTION

for external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store at 15 - 30C (59 - 86F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colirio Ocusanimage of carton label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51134-5191-5	2020-01-08	C162847	48780-1	956f9ecf-c729-621f-e053-dbdaa90a74ad	Drug Facts
51134-5191-5	2019-10-21	C162847	48780-1	956f9ecf-c729-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POLYETHYLENE GLYCOL 400	ACTIVE INGREDIENT	B697894SGQ	1
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	1
POLYETHYLENE GLYCOL 400	ACTIVE MOIETY	B697894SGQ	1
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
sodium borate	INACTIVE INGREDIENT	91MBZ8H3QO	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Colirio Ocusan
Polyethlene glycol 400 Tetrahydrozoline HCl
POLYETHYLENE GLYCOL 400
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE
benzalkonium chloride
boric acid
edetate disodium
sodium borate
sodium chloride
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51134-5191	51134-5191-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 400	B697894SGQ	ACTIB
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB
benzalkonium chloride	F5UM2KM3W7	IACT
boric acid	R57ZHV85D4	IACT
edetate disodium	7FLD91C86K	IACT
sodium borate	91MBZ8H3QO	IACT
sodium chloride	451W47IQ8X	IACT
Water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 258 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium borate	SODIUM BORATE	91MBZ8H3QO	SUSPENSION/ DROPS / OPHTHALMIC	0.03 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LOTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	INJECTION, SOLUTION / INTRAVENOUS		210 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SPRAY / NASAL		30 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	GRANULE, FOR SUSPENSION / ORAL		162 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / AURICULAR (OTIC)	0 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, DENTIFRICE / DENTAL	0.03 mg/mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SOLUTION / OPHTHALMIC	0.9 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
010cda0b-f66b-4598-bbb0-fdf67b810afd			36136ce4-9d66-4e56-bd51-0616a79a42a7	2010-07-08	Warnings	Exact identifier spl id: 010cda0b-f66b-4598-bbb0-fdf67b810afd spl set id: 36136ce4-9d66-4e56-bd51-0616a79a42a7

Reported adverse events (FAERS/openFDA)#

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