Colirio Ocusan by DLC Laboratories, Inc. Drug Facts

Colirio Ocusan by

Drug Labeling and Warnings

Colirio Ocusan by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLIRIO OCUSAN- polyethlene glycol 400 tetrahydrozoline hcl liquid 
DLC Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active Ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Purpose

Eye lubricant
Redness reliever

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

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

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.
• 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

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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

Store at 15°- 30°C (59°- 86°F)

Inactive ingredients

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

Package label

Colirio Ocusan

COLIRIO OCUSAN 
polyethlene glycol 400 tetrahydrozoline hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-5191
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
benzalkonium chloride (UNII: F5UM2KM3W7)
boric acid (UNII: R57ZHV85D4)
edetate disodium (UNII: 7FLD91C86K)
sodium borate (UNII: 91MBZ8H3QO)
sodium chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-5191-5	1 in 1 BOX	08/31/2011	12/31/2019
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/31/2011	12/31/2019

Labeler - DLC Laboratories, Inc. (093351930)

Revised: 1/2020

Document Id: 63ac1e24-fb60-451e-9711-b0ecc175556f

34390-5

Set id: 3bf7882e-cd47-432f-9eaf-ea1a6cdeeb26

Version: 7

Effective Time: 20200106

 

DLC Laboratories, Inc.