EYE LUBRICANT - polyethylene glycol 400 and propylene glycol liquid
Kareway Product, Inc.

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

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only.

Do not use

if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

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

Directions

Shake well before using.
Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

Store at room temperature.

Inactive ingredients

benzalkonium chloride, boric acid, hydrochloric acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide

Lubricant Eye Drops Ultra image of carton label

EYE LUBRICANT
polyethylene gloycol, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67510-0663
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400)	POLYETHYLENE GLYCOL 400	4 mg in 1 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL)	PROPYLENE GLYCOL	3 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE
BORIC ACID
HYDROCHLORIC ACID
POTASSIUM CHLORIDE
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67510-0663-5	1 BOTTLE ( BOTTLE) in 1 BOX	contains a BOTTLE
1		15 mL in 1 BOTTLE	This package is contained within the BOX (67510-0663-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/01/2012

Labeler - Kareway Product, Inc. (121840057)

Revised: 10/2012 Kareway Product, Inc.