Colirio Ocusan

Manufacturer: DLC Laboratories, Inc.
Effective date: 2019-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:57:39

Label at a glance#

ProductColirio Ocusan

Active ingredientPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HYDROCHLORIDE

Label structure8 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. Children under 6 years of age: ask a doctor.

Storage and handling

Store at 15°- 30°C (59°- 86°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Eye lubricant
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

When using this product

OTC - WHEN USING SECTION

pupils may become enlarged temporarily
do not touch tip of container to any surface to avoid contamination. Replace cap after using.
do not use if solution changes color or becomes cloudy
overuse may produce increased redness of the eye
remove contact lenses before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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.

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Instill 1 or 2 drops in the affected eye(s) up to four times daily. Children under 6 years of age: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at 15°- 30°C (59°- 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colirio Ocusan image of carton label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
POLYETHYLENE GLYCOL 400	ACTIVE INGREDIENT	B697894SGQ	2
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	2
POLYETHYLENE GLYCOL 400	ACTIVE MOIETY	B697894SGQ	2
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
boric acid	INACTIVE INGREDIENT	R57ZHV85D4	2
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	2
sodium borate	INACTIVE INGREDIENT	91MBZ8H3QO	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Colirio Ocusan
Polyethlene glycol 400 Tetrahydrozoline HCl
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
SODIUM BORATE
SODIUM CHLORIDE
WATER
HYDROCHLORIC ACID
POLYETHYLENE GLYCOL 400
TETRAHYDROZOLINE HYDROCHLORIDE
TETRAHYDROZOLINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24286-5191	24286-5191-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	ACTIB
TETRAHYDROZOLINE HYDROCHLORIDE	0YZT43HS7D	ACTIB

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 7 · 406 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATHECAL		9 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 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
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	GEL / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAMUSCULAR		306 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SPONGE / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	GEL / TOPICAL		10 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / TOPICAL	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	POWDER, FOR SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 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
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 148 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
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVESICAL		351 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / AURICULAR (OTIC)	0.37 %w/v		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
boric acid	BORIC ACID	R57ZHV85D4	GEL / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 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
97f4abe9-63ec-7664-e053-2a95a90aaa09			3bf7882e-cd47-432f-9eaf-ea1a6cdeeb26	2019-11-22	Warnings	Exact identifier spl id: 97f4abe9-63ec-7664-e053-2a95a90aaa09 spl set id: 3bf7882e-cd47-432f-9eaf-ea1a6cdeeb26

Reported adverse events (FAERS/openFDA)#

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