LEADER ORIGINAL FORMULA- tetrahydrozoline hydrochloride solution

LEADER ORIGINAL FORMULA by

Drug Labeling and Warnings

LEADER ORIGINAL FORMULA by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                    Purpose

Tetrahydrozoline HCL 0.05%....................Redness reliever

PURPOSE

Uses

For the relief of redness of the eyes due to minor eye irritations.

WARNINGS

Warnings

Ask a doctor before use if you have narrow angle glaucoma

WHEN USING

When Using this product

• pupils may become enlarged temporarily
• overuse may cause more eye redness
• remove contact lenses before using
• do not use if this solution changes color or become cloudy
• to avoid contamination, do not touch tip of container to any surface
• 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 the eye lasts
• condition worsens 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

• to open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turning.
• put 1 to 2 drops in the affected eye(s) up to 4 times daily
• children under 6 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• some users may experience a brief tingling sensation
• store at 15 to 25°C (59 to 77°F)

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN2260040

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER ORIGINAL FORMULA 
tetrahydrozoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-139
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

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 BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-139-05	1 in 1 CARTON	03/22/2017
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/04/2012

Labeler - CARDINAL HEALTH (097537435)