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Name:Artifical Tears
Manufacturer:Wal-mart Stores Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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

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

Walmart Artificial Tears

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 Item Code (Source) NDC:49035-454
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 0.3 g  in 100 mL
PROPYLENE GLYCOL (PROPYLENE GLYCOL) PROPYLENE GLYCOL 1 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
BORIC ACID  
EDETATE DISODIUM  
POTASSIUM CHLORIDE  
WATER  
SODIUM BORATE  
SODIUM CHLORIDE  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-454-15 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (49035-454-15)

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

Labeler - Wal-Mart Stores Inc (051957769)
Registrant - Baush & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 114406598 MANUFACTURE

Revised: 09/2010 Wal-Mart Stores Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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