LEADER RELIEF   - tetrahydrozoline hydrochloride and zinc sulfate solution 
HANLIM PHARM. CO., LTD.

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Drug Facts

Active ingredients                                                                            Purpose

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

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

Uses

• for the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.
• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
  

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

• remove contact lenses before using
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use
  

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
  
• redness or irritation of eye gets worse or lasts more than 72 hours
  

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

• instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
• Store at room temperature.
• Children under 6 years of age: Ask a doctor
  

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

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LEADER RELIEF   tetrahydrozoline hydrochloride and zinc sulfate   solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11716-9638 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg  in 1 mL ZINC SULFATE (ZINC) ZINC SULFATE 2.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE   BORIC ACID   EDETATE DISODIUM   WATER   SODIUM CHLORIDE   SODIUM CITRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11716-9638-3 1 BOTTLE In 1 CARTON contains a BOTTLE 1 15 mL In 1 BOTTLE This package is contained within the CARTON (11716-9638-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/08/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Operations
HANLIM PHARM. CO., LTD.		687986034	manufacture

Revised: 10/2010HANLIM PHARM. CO., LTD.