SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]

SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]
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NDC 0065-0509-35
Set ID 4689c59c-5721-3f91-6c85-e41501998fd0
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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

  • Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredientsPurpose
    Mineral Oil 3%Lubricant
    White Petrolatum 94%Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • Warnings

    For external use only
    Do not use

    • if you are sensitive to any ingredient in this product
  • When using this product

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

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

    • eye pain
    • changes in vision
    • continued redness or irritation of the eye
    • condition worsens or persist for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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

    • Not for use with contact lenses
    • Store at 46° - 80° F (8° - 27° C)
  • Inactive ingredient

    anhydrous liquid lanolin 3%

  • QUESTIONS

    Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com 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)

    Carton

    Systane®
    LUBRICANT EYE OINTMENT

    NIGHTTIME
    SEVERE DRY EYE RELIEF

    For nighttime protection from further irritation

    Systane® 
    LUBRICANT EYE OINTMENT


    NIGHTTIME
    SEVERE DRY EYE RELIEF

    #1 DOCTOR RECOMMENDED BRAND1

    Intensive relief
    Preservative free

    OINTMENT


    Alcon®

    STERILE

    3.5 g Tube (1/8 OZ NET WT)

    TAMPER EVIDENT: Prior to use,
    inspect the product container. If "skirt"
    on bottom of cap is visible, do not use.

    1 Based on  a survey of eye care professionals.
       Data on file.

    47868-2

    LOT:
    EXP.:


    Systane®
    LUBRICANT EYE OINTMENT


    Alcon

    Made in Belgium
    ALCON LABORATORIES, INC.
    Fort Worth, Texas 76134 USA

    carton 0065-0509
  • INGREDIENTS AND APPEARANCE
    SYSTANE NIGHTTIME 
    mineral oil and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0509
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil30 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum940 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Lanolin (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0509-351 in 1 CARTON06/26/2008
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    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/FEIBusiness Operations
    S.A. Alcon-Couvreur N.V.370205429manufacture(0065-0509)