OPTICAL ADVANCED EYE  - dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution/ drops 
TELEVISA CONSUMER PRODUCTS USA

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                                                        Purpose

Dextran 70 0.1%..........................................................Lubricant

Polyethylene Glycol 400 1% ........................................Lubricant

Povidone 1% ..............................................................Lubricant

Tetrahydrozoline HCL 0.05% .......................................Redness reliever

Uses

Ask a doctor before use if you have narrow angle glaucoma

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

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

Directions

Other information

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

DISTRIBUTED BY:

TELEVISA CONSUMER PRODUCTS USA, LLC

4550 POST OAK PLACE SUITE 326

HOUSTON, TX 77027

MADE IN KOREA

image of carton label

OPTICAL ADVANCED EYE  
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55038-002
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 701 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE10 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 CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55038-002-151 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/31/2012
Labeler - TELEVISA CONSUMER PRODUCTS USA (840246230)

Revised: 10/2012
Document Id: c67a0356-7f0e-4060-8c7f-8db6df7a8a36
Set id: 0d9a8939-6386-4564-8117-c4063017e281
Version: 2
Effective Time: 20121031
 
TELEVISA CONSUMER PRODUCTS USA