Label: MINERAL OIL- lacri-lube 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 February 17, 2011

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  • Active ingredient

    Mineral Oil 42.5%

    White Petrolatum 56.8%

  • Purpose

    Eye lubricant

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    For use as a protectant against further irritation or to relieve dryness or the eye.

  • Warnings

    For external use only.

    To avoid contamination, do not touch tip of container to any surface.

    Replace cap after using.

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

  • 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

    Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

    Store away from heat. Protect from freezing.

    Use before expiration date marked on container.

    RETAIN THIS CARTON FOR FUTURE REFERENCE.

  • Inactive ingredients

    Chlorobutanol and lanolin alcohols.

  • Package/Label Principal Display Panel

    Lacri-Lube

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL 
    lacri-lube ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-681(NDC:0023-0312)
    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) PETROLATUM568 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-681-353.5 g in 1 TUBE
    2NDC:21695-681-077 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/30/2007
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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