Label: LEADER LUBRICANT EYE- mineral oil, and white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 3, 2024

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Mineral oil 42.5%........................................................ Eye Lubricant

    White petrolatum 57.3%............................................. Eye Lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation
  • WARNINGS

    Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface.
    • Keep tube tightly closed.
  • STOP USE

    Stop use and ask a doctor if:

    • You experience eye pain, changes in vision, continued redness or irritation of the eye.
    • The condition worsens or persists 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 at 1-800-222-1222.

  • INDICATIONS & USAGE

    Directions

    • Wash your hands.
    • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.

  • STORAGE AND HANDLING

    Other information

    • store away from heat
    • protect from freezing
    • use before expiration date on the tube
    • store at 59°-86° (15°-30°)
  • INACTIVE INGREDIENT

    Inactive ingredient

    lanolin alcohol

  • DOSAGE & ADMINISTRATION

    Directions

    • Wash your hands.
    • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.

  • PRINCIPAL DISPLAY PANEL

    Leader Lubricant Eye Ointment

    Principal Display Panel

    Bottle

    Carton

  • INGREDIENTS AND APPEARANCE
    LEADER LUBRICANT EYE 
    mineral oil, and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0513
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL425 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM573 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0513-11 in 1 BOX08/30/2019
    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 DrugM01808/30/2019
    Labeler - Leader (063997360)