DRY EYES (WHITE PETROLATUM MINERAL OIL) OINTMENT [CARDINAL HEALTH]

DRY EYES (WHITE PETROLATUM MINERAL OIL) OINTMENT [CARDINAL HEALTH]
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NDC 37205-134-79
Set ID 3f12cba7-2772-4eb7-ac82-2a53d517c3ba
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredients

    Mineral oil 15%
    White petrolatum 83%

  • Purpose

    Lubricant

  • Uses

    • to prevent further irritation
    • to relieve dryness of the eye
  • Warnings

    When using this product  

    • replace cap after use
    • do not touch tip of container to any surface to avoid contamination

    Stop use and ask a doctor if

    • condition worsens or persists for more than 72 hours
    • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • 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(s)
     
    apply a small amount (1/4 inch) of ointment to the inside of eyelid
     
    apply one or more times daily or as directed by a doctor
  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • keep tightly closed
    • see crimp of tube or carton for Lot Number and Expiration Date

     

  • Inactive ingredient

    lanolin oil

  • Questions?

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

    1-800-323-0000

    DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

  • Package/Label Principal Display Panel

    Carton

    NDC 37205-134-79

    LEADER®

    Compare to Refresh P.M. active ingredient*

    Dry Eyes

    Lubricant Eye Ointment
    (Sterile)

    Preservative Free

    Prevents irritation & relieves dryness of the eye

    SATISFACTION GUARANTEED Net wt. 1/8 oz. (3.5 g)

  • INGREDIENTS AND APPEARANCE
    DRY EYES 
    white petrolatum mineral oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-134
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM830 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-134-793.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/15/2011
    Labeler - Cardinal Health (097537435)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated807927397MANUFACTURE

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