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

Systane

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

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

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

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE AND ASK A DOCTOR IF SECTION

  • 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, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. 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

9005989-0610

PRINCIPAL DISPLAY PANEL

Systane®
GEL DROPS
LUBRICANT EYE GEL

ANYTIME PROTECTION

INTENSIVE GEL SHIELD
EASY APPLICATION
ENDURING RELIEF

Alcon®
STERILE
10 mL (⅓ FL OZ)

Systane

polyethylene glycol 400 and propylene glycol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0065-0454
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
EDETATE DISODIUM
GUAR GUM
Polidronium Chloride
potassium chloride
SODIUM CHLORIDE
sorbitol
water
HYDROCHLORIC ACID
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0065-0454-07 10 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2011-02-09


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Be sure to consult your doctor before taking any medication!
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