Label: REFRESH LACRI-LUBE- mineral oil, petrolatum ointment

  • NDC Code(s): 0023-0312-04, 0023-0312-07
  • Packager: Allergan, Inc.
  • 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 December 1, 2022

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  • Active ingredients

    Mineral Oil 42.5%

    White Petrolatum 56.8%

  • Purpose

    Eye lubricant

    Eye lubricant

  • Uses

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

    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

    • Store away from heat.
    • Protect from freezing.
    • Use only if tape seals on top and bottom flaps are intact.
    • Use before expiration date marked on container.
    • Store at 59°-77°F (15°-25°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Chlorobutanol and Lanolin alcohols.

  • Questions or comments?

    1.800.678.1605

    refreshbrand.com

  • Principal Display Panel

    NDC 0023-0312-04

    Lubricant Eye Ointment

    Refresh®
    LACRI-LUBE®

    Nighttime Relief for
    Intense Eye Dryness

    Net wt. 0.12 oz (3.5 g) Sterile

    Principal Display Panel NDC 0023-0312-04 Lubricant Eye Ointment Refresh® LACRI-LUBE® Nighttime Relief for Intense Eye Dryness Net wt. 0.12 oz (3.5 g) Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH LACRI-LUBE 
    mineral oil, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:0023-0312-041 in 1 CARTON12/15/1977
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0023-0312-071 in 1 CARTON12/15/1977
    27 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/15/1977
    Labeler - Allergan, Inc. (144796497)
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