Drug Details [pdf]

ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution/ drops
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Polyvinyl alcohol - Eye lubricant

Povidone - Eye lubricant

Keep out of reach of children

If accidental ly swallowed, get medical help or contact a Poison Control Center immediately.

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

For external use only

Do not use this product if solution changes color or becomes cloudy

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

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

Directions

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

Inactive ingredients

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

Other information

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

Carton

ARTIFICIAL TEARS
polyvinyl alcohol, povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0101
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62011-0101-1	1 in 1 CARTON	03/01/2012	12/31/2015
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/01/2012	12/31/2015

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceutical, Inc.		174450460	manufacture(62011-0101) , pack(62011-0101) , label(62011-0101)

Revised: 10/2019

Document Id: 94886653-2c5e-544a-e053-2995a90aed23

Set id: ecaa0eba-1662-4394-b26f-a765f422dcea

Version: 2

Effective Time: 20191009

Strategic Sourcing Services LLC

Drug Labeling and Warnings

Drug Details [pdf]