SHOPKO DRY EYE RELIEF - glycerin  solution 
HANLIM 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                                                        Purpose

Glycerin 0.2% ............................................................Lubricant

Hypromellose 0.2% .....................................................Lubricant

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

Uses

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: ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycine magnesium chloride,

potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, and sodium lactate

image of carton labelEnter section text here

SHOPKO DRY EYE RELIEF 
glycerin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1629
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.002 mL  in 1 mL
HYPROMELLOSE (UNII: 3NXW29V3WO) (HYPROMELLOSE - UNII:3NXW29V3WO) HYPROMELLOSE0.002 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
DEXTROSE (UNII: IY9XDZ35W2)  
GLYCINE (UNII: TE7660XO1C)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-1629-31 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/12/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 8/2010
Document Id: babce0c4-1715-4831-9a4b-21d0c307e278
Set id: ab5e9ef8-34a5-4786-9e86-adb91595997b
Version: 1
Effective Time: 20100812
 
HANLIM PHARM. CO., LTD.