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Systane Ultra
2013-11-09 22:46:39 来源: 作者: 【 】 浏览:1641次 评论:0
Dosage form: solution/ drops
Ingredients: Polyethylene Glycol 400 4mg in 1mL, Propylene Glycol 3mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-1431 
Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 400 0.4%
Propylene Glycol 0.3%

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning and irritation due to dryness of the eye
WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use
OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION
  • Shake well before using.
  • Instill 1 or 2 drops in the affected eye(s) as needed.
OTHER SAFETY INFORMATION
  • Store at room temperature.
INACTIVE INGREDIENT SECTION

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
www.systane.com
MedInfo@AlconLabs.com

PRINCIPAL DISPLAY PANEL

Systane®
ULTRA

LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Brand1

Alcon®


STERILE
10 mL (⅓ FL OZ)

9006416-0111

 

 

SYSTANE ULTRA  
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1431
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 4 mg  in 1 mL
Propylene Glycol (Propylene Glycol) Propylene Glycol 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Aminomethylpropanol  
Boric Acid  
Guar Gum  
Polidronium Chloride  
Potassium Chloride  
Water  
Sodium Chloride  
Sorbitol  
Hydrochloric Acid  
Sodium Hydroxide  
 
Packaging
# Item Code Package Description
1 NDC:0065-1431-05 1 BOTTLE, DROPPER in 1 CARTON
1   10 mL in 1 BOTTLE, DROPPER
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 11/30/2009  
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Laboratories, Inc.   008018525 MANUFACTURE(0065-1431)

 

Revised: 06/2011
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