OPTI-FREE - propylene glycol emulsion
Alcon Laboratories, 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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Drug Facts

Active ingredients	Purpose
Propylene Glycol 0.6%	Lubricant

Uses

For use as a protectant against further irritation or to relieve dryness of the eye
For use as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

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

When using this product

remove contact lenses before using
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 experience any of the following:

eye pain
changes in vision
continued redness or irritation of the eye
condition worsens or persists for 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 1–2 drops in the affected eye(s), as needed

Other information

Store at room temperature

Inactive ingredients:

boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD* (polyquarternium-1) 0.001% preservative, sorbitan tristearate, sorbitol, and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195

www.opti-free.com

alcon.medinfo@alcon.com

Principal Display Panel

OPTI-FREE*

LUBRICANT EYE DROPS

FOR ON EYE USE

10 mL

STERILE

Alcon®
a Novartis company

OPTI-FREE
propylene glycol emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-1501
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.06 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (UNII: BI71WT9P3R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GUAR GUM (UNII: E89I1637KE)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
Polidronium Chloride (UNII: 6716Z5YR3G)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0065-1501-10	1 in 1 CARTON	06/18/2015	03/31/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:0065-1501-11	2 in 1 CARTON	06/18/2015	01/31/2018
2		10 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	06/18/2015	03/31/2018

Labeler - Alcon Laboratories, Inc. (008018525)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Research Ltd		007672236	manufacture(0065-1501)

Revised: 12/2018

Document Id: 228bab5f-bc39-4571-bde5-b5f8814d1780

Set id: 7afa70d5-2cc9-fb7d-4f1f-10e7ebade092

Version: 3

Effective Time: 20181227

Alcon Laboratories, Inc.