Systane Ultra description, usages, side effects, indications, overdosage, supplying and lots more!

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Systane Ultra

Alcon Laboratories, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 label 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 4 mg
propylene glycol Propylene Glycol 3 mg

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 Marketing Start Date Marketing End Date
1 10 in 1 BOTTLE, DROPPER
2 NDC:0065-1431-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2009-11-30


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Be sure to consult your doctor before taking any medication!
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