ARTIFICAL TEARS- glycerin and propylene glycol solution/ drops

Artifical Tears by

Drug Labeling and Warnings

Artifical Tears by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Baush & Lomb Incorporated, Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Glycerin (0.3%)

Propylene glycol (1.0%)

Purpose

Lubricant

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°-25°C (59°-77°F)
• keep tightly closed
• use before expiration date marked on the carton and bottle
• serious side effects associated with use of the product may be reported to the phone number provided below

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?

Call: 1-866-767-8975

U.S. Patent No. 5,800,807

DISTRIBUTED BY: RITE AID

30 HUNTER LANE, CAMP HILL, PA 17011

MADE IN USA

© RITE AID

ITEM 398549

3123703

Package/Label Principal Display Panel

RITE

AID®

PHARMACY

eye care

artificial

tears

lubricant eye drops

DRY EYE FORMULA

fast relief from

age-related dry eyes

replenishes tears

refreshes eyes

Sterile

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

ARTIFICAL TEARS 
glycerin and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-9854
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.3 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-9854-9	1 in 1 CARTON	09/01/2010
1		30 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	09/01/2010

Labeler - Rite Aid Corporation (014578892)

Registrant - Baush & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		114406598	MANUFACTURE(11822-9854)