Drug Labeling and Warnings

Drug Details

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EYE STREAM- purified water solution 
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

NDC: 0065-0530-01

Active IngredientPurpose
Purified Water 98.6%                  Eye Irrigation

Inactive Ingredients

Benzalkonium Chloride 0.013% as preservative, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Chloride, Sodium Citrate Dihydrate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.  The pH range of solution is in the physiologic range.

Uses

For irrigating the eye to help relieve irritation, discomfort and burning by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.

Warnings

For external use only
Obtain immediate medical treatment for all open wounds in or near the eyes. 
This product is not to be used as a saline solution for rinsing and soaking soft contact lenses.

NOT FOR INJECTION OR INTRAOCULAR SURGERY.

Do not use

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

When using this product

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

 Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness
  • irritation of the eye
  • if the 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

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other Information

Store at 8o – 27oC (46o – 80oF)

Questions?

In the U.S.,
Call 1-800-757-9195

Drug Facts

NDC: 0065-0530-04

Active IngredientsPurpose
Purified Water 98.6%                  Eye Irrigation

Uses

For irrigating the eye to help relieve irritation, discomfort and burning by removing loose foreign material, air pollutants, (smog or pollen), or chlorinated water.

Warnings

For external use only

Obtain immediate medical treatment for all open wounds in or near the eyes.

This product is not to be used as a saline solution for rinsing and soaking soft contact lenses.

NOT FOR INJECTION OR INTRAOCULAR SURGERY.

Do not use

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

When using this product

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

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness
  • irritation of the eye
  • if the 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

Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other Information

Store at 8°-27°C (46°-80° F)

Inactive Ingredients

Benzalkonium Chloride 0.013% as a preservative, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Citrate Dihydrate, Sodium Chloride and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.  The pH of the solution is in the physiological range.

Questions?

In the U.S., Call 1-800-757-9195
[email protected]

PRINCIPAL DISPLAY PANEL

NDC  0065-0530-01  

eye stream
®
eye wash solution sterile  

Alcon®

1 FL OZ (30 mL)

Eye Stream Carton Image 1 oz

PRINCIPAL DISPLAY PANEL

NDC 0065-0530-04

eye stream®

eye wash solution
sterile

Alcon®

4 FL OZ (118 mL)

Eye Stream Carton Image 4 oz
EYE STREAM 
purified water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0065-0530
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water986 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Calcium Chloride (UNII: M4I0D6VV5M)  
Magnesium Chloride (UNII: 02F3473H9O)  
Potassium Chloride (UNII: 660YQ98I10)  
Sodium Acetate (UNII: 4550K0SC9B)  
Sodium Chloride (UNII: 451W47IQ8X)  
Trisodium Citrate Dihydrate (UNII: B22547B95K)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Hydrochloric Acid (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0065-0530-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/1990
2NDC: 0065-0530-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/1990
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/30/1990
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research Ltd007672236MANUFACTURE(0065-0530)

Revised: 12/2017
 
Alcon Laboratories, Inc.


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