PREMIER VALUE STERILE EYE DROPS- dextran 70 polyethylene glycol 400 povidone tetrahydrozoline hci solution/ drops 
Chain Drug Consortium, LLC

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                                            Purpose

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

Polyethylene glycol 400 1%............................. Lubricant

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

Tetrahydrozoline HCI 0.05%............................ Redness Reliever

Uses

Warnings

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 our of the reach of children. If swallowed, get medical help or contact a Poision Control Center right away.

Directions

Other information

Inactive ingredients

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

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431 USA

image description

PREMIER VALUE STERILE EYE DROPS 
dextran 70 polyethylene glycol 400 povidone tetrahydrozoline hci solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-449
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70.001 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400.01 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE.01 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE.0005 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORATE (UNII: T95DR77GMR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-449-001 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/23/2014
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 1/2014
Document Id: bd295fc2-574d-4eb4-8c10-cc614bdd5b89
Set id: 64317c9b-4005-4082-a9ad-362155aafc67
Version: 1
Effective Time: 20140123
 
Chain Drug Consortium, LLC