COLIRIO OCUSAN  - polyethylene glycol 400 and tetrahydrozoline hydrochloride 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.

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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
  • 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°- 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 Ocusanimage of carton label

COLIRIO OCUSAN  
polyethlene glycol 400 tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24286-5191
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 4000.15 mL  in 15 mL
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.0075 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
boric acid 
edetate disodium 
sodium borate 
sodium chloride 
Water 
HYDROCHLORIC ACID 
Packaging
#Item CodePackage Description
1NDC:24286-5191-51 in 1 BOX
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/31/2011
Labeler - DLC Laboratories, Inc. (093351930)

Revised: 08/2011
 
DLC Laboratories, Inc.