SHOPKO RELIEF  - 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 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

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

www.ueccorp.com

image of carton labelEnter section text here

SHOPKO RELIEF  
tetrahydrozoline hydrochloride and zinc sulfate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0460
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:11716-0460-11 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/08/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIBusiness Operations
HANLIM PHARM. CO., LTD.687986034manufacture

Revised: 10/2010
Document Id: 505ed84a-9943-43b3-9240-f47cb0a6ea3c
Set id: 4c732e9c-4d64-4deb-83d9-ffeb5da72c26
Version: 3
Effective Time: 20101008
 
HANLIM PHARM. CO., LTD.