LEADER 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

For external use only.

Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

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 Cardinal Health

Dublin, OH 43017

CIN 1963735

www.myleader.com

1-800-200-6313

image of carton labelEnter section text here

LEADER RELIEF  
tetrahydrozoline hydrochloride and zinc sulfate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-9638
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:11716-9638-31 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: 7ccb006e-809f-4f34-9695-f4e93fc39f51
Set id: 00bb8c06-9852-4b8b-845d-c15dfd8bc5ef
Version: 2
Effective Time: 20101008
 
HANLIM PHARM. CO., LTD.