Label: SYSTANE NIGHTTIME- mineral oil and white petrolatum ointment

  • NDC Code(s): 0065-0509-35
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2024

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  • SPL UNCLASSIFIED SECTION

  • 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 8° - 27° C (46° - 80° F)
  • 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

    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: For your protection,
    do not use if carton security seal is damaged
    or missing at the time of purchase.

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

    1635970-0623

    LOT:
    EXP.:


    Systane®
    LUBRICANT EYE OINTMENT

    Alcon

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

    Carton Front
    Carton Back

    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: For your protection, do not use if carton security seal is damaged or missing at the time of purchase.

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

    3601179 01-1024

    Systane®
    LUBRICANT EYE OINTMENT

     Alcon

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

    Carton2 Front
    Carton2 Back
  • 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 DrugM01806/26/2008
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novartis Manufacturing370205429manufacture(0065-0509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Siegfried El Masnou, S.A.462029349manufacture(0065-0509)
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