LEADER EYE DROPS REDNESS RELIEF- glycerin, naphazoline hydrochloride liquid

Leader Eye Drops Redness Relief by

Drug Labeling and Warnings

Leader Eye Drops Redness Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purposes

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Uses

• for the relief of redness of the eye due to minor eye irritations
• for the temporary relief of burning and irritation due to dryness of the eye 
• for use as a protectant against further irritation or dryness of the eye

Warnings

For external use only

Do not use

• if solution changes color or becomes cloudy

Ask a doctor before use if you have

narrow angle glaucoma

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using
• overuse may produce increased redness of the eye
• pupils may become enlarged temporarily

Stop use and ask a doctor if

• you experience eye pain
• you experience changes in vision
• you experience continued redness or irritation of the eye
• the condition worsens or persists for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age:ask a doctor

Other information

• store at room temperature
• remove contact lenses before using

Inactive ingredients

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

Questions or comments?

Call 1-888-527-4276

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER EYE DROPS REDNESS RELIEF 
glycerin, naphazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0010
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0010-1	1 in 1 CARTON	04/30/2019
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 70000-0010-2	2 in 1 CARTON	04/30/2019
2		15 mL in 1 BOTTLE, PLASTIC; 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	04/30/2019

Labeler - Cardinal Health (097537435)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(70000-0010) , pack(70000-0010) , label(70000-0010)