ARTIFICAL TEARS- glycerin and propylene glycol solution/ drops
Wal-Mart Stores 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 ingredient

Glycerin (0.3%)

Propylene glycol (1.0%)

Purpose

Lubricant

Uses

temporary relief of burning and irritation due to dryness of the eye
prevents further irritation

Warnings

Do not use

if solution changes color or becomes cloudy

When using this product

do not touch tip of container to any surface to avoid contamination
remove contact lenses before using
replace cap after use

Stop use and ask a doctor if

you experience 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

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

Other information

store at 15°-30°C (59°-86°F)
keep tightly closed
use before expiration date marked on the carton and the bottle

Inactive ingredients

benzalkonium chloride (0.01%), boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions and Comments

Call: 1-800-553-5340

Package/Label Principal Display Panel

artificial tears

LUBRICANT EYE DROPS

Soothing Relief

STERILE

0.5 FL OZ (15 mL)

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT

ARTIFICAL TEARS
glycerin and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:49035-454
Route of Administration	OPHTHALMIC	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (GLYCERIN)	GLYCERIN	0.3 g in 100 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL)	PROPYLENE GLYCOL	1 mL in 100 mL

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

#	Item Code	Package Description
Packaging
1	NDC:49035-454-15	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/01/2010

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Baush & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		114406598	MANUFACTURE

Revised: 9/2010

Document Id: 99cfea82-afb8-4c5f-ac0c-492204a42c08

Set id: 99cfea82-afb8-4c5f-ac0c-492204a42c08

Version: 1

Effective Time: 20100901

Wal-Mart Stores Inc