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Systane Nighttime

Dosage form: ointment
Ingredients: Mineral Oil 30mg in 1g, Petrolatum 940mg in 1g
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-0509

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Systane® Nighttime

Drug Facts

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)

SYSTANE NIGHTTIME  
mineral oil and white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0509
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (Mineral Oil) Mineral Oil30 mg  in 1 g
Petrolatum (Petrolatum) Petrolatum940 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Lanolin 
Packaging
#Item CodePackage Description
1NDC:0065-0509-351 TUBE (TUBE) in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34906/26/2008
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIOperations
S.A. Alcon-Couvreur N.V.370205429MANUFACTURE

Revised: 08/2010
 
Alcon Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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