LEADER RELIEF- tetrahydrozoline hydrochloride and zinc sulfate solution

LEADER RELIEF by

Drug Labeling and Warnings

LEADER RELIEF by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                            Purpose

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

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

PURPOSE

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

Warnings

For external use only.

DO NOT USE

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

WHEN USING

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

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
  

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

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

INDICATIONS & USAGE

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 INGREDIENT

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

DOSAGE & ADMINISTRATION

Distributed By Cardinal Health

Dublin, OH 43017

CIN 1963735

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LEADER RELIEF  
tetrahydrozoline hydrochloride and zinc sulfate solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC - UNII:J41CSQ7QDS)	ZINC SULFATE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-9638-3	1 in 1 CARTON
1		15 mL in 1 BOTTLE

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	Business Operations
HANLIM PHARM. CO., LTD.		687986034	manufacture