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

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Systane

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Hypromellose (0.3%)

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
  • As a protectant against further irritation.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • if gel 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. Replace cap after using.

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for 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

Put 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

Store between 15°- 30°C (59°- 86°F).

INACTIVE INGREDIENT SECTION

Carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

In the U.S., call toll-free 1-866-393-6336;
MedInfo@AlconLabs.com

Serious side effects associated with use of this product may be reported to this telephone number.

PRINCIPAL DISPLAY PANEL

NDC 0065047401

Systane® GEL

LUBRICANT EYE GEL

OVERNIGHT THERAPY

Delivers long-lasting relief of dry eye symptoms

Alcon®
STERILE
10g (0.34 FL OZ)

Systane

hypromellose GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0065-0474
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HYPROMELLOSE 2910 (4000 MPA.S) 3 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
Phosphonic Acid
water
SODIUM PERBORATE
sorbitol
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0065-0474-01 10 in 1 TUBE
2 NDC:0065-0474-02 3.5 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2012-12-15


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