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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 11, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • 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 finalpart34908/30/2019
    Labeler - Leader (063997360)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!