ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops

Artificial Tears by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

PURPOSE

Purposes

Polyvinyl alcohol ......Lubricant

Povidone.....................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

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

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

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other information

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, sodium phosphate monobasic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-008
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990)	POLYVINYL ALCOHOL, UNSPECIFIED	5 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE (UNII: IY9XDZ35W2)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-008-01	1 in 1 CARTON	11/25/2003
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	11/25/2003

Labeler - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(55651-008) , pack(55651-008) , label(55651-008)