ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol, povidone solution/ drops

Artificial Tears Lubricant Eye by

Drug Labeling and Warnings

Artificial Tears Lubricant Eye by is a Otc medication manufactured, distributed, or labeled by WinCo Foods, LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

PURPOSE

​Purpose

Polyvinyl alcohol: Eye Lubricant

Povidone: Eye Lubricant

INDICATIONS & USAGE

Uses:

• for use as a protectant against further irritation or to relieve dryness of the eye
• 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 this product if solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

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

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed
• remove contact lens before using

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

Other information

• Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
• RETAIN THIS CARTON FOR FUTURE REFERENCE
• Store at 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS LUBRICANT EYE 
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67091-284
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	500 mg  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	600 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67091-284-15	1 in 1 BOX	01/09/2015
1		15 mL in 1 BOTTLE, DROPPER; 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	01/09/2015

Labeler - WinCo Foods, LLC (056098817)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(67091-284) , label(67091-284) , pack(67091-284)