PREMIER VALUE EYE AC - tetrahydrozoline hydrochloride and zinc sulfate 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

Tetrahydrozoline HCL 0.05% ...........................................................Redness Reliever

Zinc Sulfate 0.25% .........................................................................Astringent

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 out of the reach of children.

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

Directions

Inactive ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

Distributed By:

Chain Drug Consortium, LLC.

3301 NW Boca Raton Blvd. Suite 101

Boca Raton, FL 33431

image of carton labelEnter section text here

PREMIER VALUE EYE AC 
tetrahydrozoline hydrochloride and zinc sulfate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0103
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC - UNII:J41CSQ7QDS) ZINC SULFATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-0103-21 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/02/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 11/2010
Document Id: f02c0b6e-3369-43fe-b992-0ad9d84f2191
Set id: 19a9736c-4278-44c3-aef5-3f3bb7708666
Version: 2
Effective Time: 20101102
 
HANLIM PHARM. CO., LTD.