Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

k">

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 image of carton label

COLIRIO OCUSAN 
polyethlene glycol 400 tetrahydrozoline hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24286-5191
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 24286-5191-51 in 1 BOX08/31/2011
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/31/2011
Labeler - DLC Laboratories, Inc. (093351930)

Revised: 2/2019
 
DLC Laboratories, Inc.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.