Colirio Ocusan by Samchundang Pharm. Co., Ltd. Drug Facts

Colirio Ocusan by

Drug Labeling and Warnings

Colirio Ocusan by is a Otc medication manufactured, distributed, or labeled by Samchundang Pharm. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLIRIO OCUSAN- polyethlene glycol 400 tetrahydrozoline hcl liquid 
Samchundang Pharm. Co., Ltd.

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.

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Drug Facts

Active Ingredients

Active Ingredients                              Purpose

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

Tetrahydrozoline HCl 0.05%..........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

• 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

• 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.

Other Information

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

Inactive Ingredients

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

Colirio Ocusan

COLIRIO OCUSAN 
polyethlene glycol 400 tetrahydrozoline hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51134-5191
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51134-5191-5	1 in 1 BOX	08/01/2010	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	08/01/2010	12/31/2019

Labeler - Samchundang Pharm. Co., Ltd. (687792325)

Revised: 1/2020

Document Id: 49e5f969-7772-46eb-9ce9-b1d9d0d4d2af

34390-5

Set id: 36136ce4-9d66-4e56-bd51-0616a79a42a7

Version: 2

Effective Time: 20200106