ARTIFICAL TEARS- polyvinyl alcohol, and povidone solution/ drops

Artifical Tears by

Drug Labeling and Warnings

Artifical Tears by is a Otc medication manufactured, distributed, or labeled by medsource pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                  Purpose

Polyvinyl alcohol 0.5%............................Lubricant

Povidone 0.6%......................................Lubricant

PURPOSE

Uses

• For the temporary relief of burning & irritation due to dryness of the eye
• For use as a protectant against further irritation or to relieve dryness of the eye

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use

• if solution changes color or becomes cloudy.

WHEN USING

When using this product

• to avoid contamination, do not touch tip to any surface
• replace cap after using

STOP USE

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
• symptoms last for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• store at room temperature
• remove contact lenses before using

INACTIVE INGREDIENT

Inactive ingredients

benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

DOSAGE & ADMINISTRATION

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree, City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTIFICAL TEARS 
polyvinyl alcohol, and povidone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45865-744(NDC:50804-017)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	0.05 g  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	0.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45865-744-01	1 in 1 PACKAGE	06/01/2018
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	04/04/2016

Labeler - medsource pharmaceuticals (833685915)

Establishment
Name	Address	ID/FEI	Business Operations
medsource pharmaceuticals		833685915	repack(45865-744)