FREDS ADVANCED EYE DROPS - dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution 
FREDS, 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                                                        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: Fred's, Inc.

4300 New Getwell Rd., Memphis, TN 38118

www.fredsinc.com

Made in Korea

image of carton label

FREDS ADVANCED EYE DROPS 
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-118
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:55315-118-151 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/15/2012
Labeler - FREDS, INC (005866116)

Revised: 10/2012
Document Id: 39f6f573-e51d-4669-8273-3ef195025762
Set id: e34d24da-9f44-4bbb-9b1d-2aa175f578f8
Version: 2
Effective Time: 20121015
 
FREDS, INC