SYSTANE NIGHTTIME- mineral oil and white petrolatum ointment

Systane Nighttime by

Drug Labeling and Warnings

Systane Nighttime by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., S.A. Alcon-Couvreur N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 3%
White Petrolatum 94%

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

• if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION 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

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

• Store at 8°-27°C (46°-80°F).

INACTIVE INGREDIENT SECTION

Anhydrous Liquid Lanolin 3%.

OTC - QUESTIONS SECTION

In the U.S., call 1-800-757-9195 or visit www.systane.com

PRINCIPAL DISPLAY PANEL

FOR NIGHTTIME PROTECTION OF DRY EYES

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

OVERNIGHT RELIEF

DRY EYE THERAPY

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

Systane® Nighttime Lubricant Eye Ointment is a safe and effective formulation with no preservatives. This unpreserved ointment, when applied to the eyes, forms a smooth comfortable protective film, especially useful for nighttime protection and lubrication of dry eyes.

PRESERVATIVE-FREE

Alcon®
STERILE
3.5 g Tube (1/8 OZ NET WT)

INGREDIENTS AND APPEARANCE

SYSTANE NIGHTTIME 
mineral oil and white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0509
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	30 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	940 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Lanolin (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0509-35	1 in 1 CARTON	06/26/2008
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	06/26/2008

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
S.A. Alcon-Couvreur N.V.		370205429	manufacture(0065-0509)