Label: REFRESH P.M.- mineral oil, petrolatum ointment

  • NDC Code(s): 0023-0240-04, 0023-0240-21
  • 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 August 17, 2014

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

  • Active ingredients

    Mineral Oil 42.5%

    White Petrolatum 57.3%

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  • Purpose

    Eye lubricant

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  • 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.
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  • 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.

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  • 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.

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  • Other information

    • Store away from heat.
    • Protect from freezing.
    • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
    • Use before expiration date marked on container.
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
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  • Inactive ingredients

    Lanolin alcohols.

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  • Questions or comments?

    1.800.433.8871

    refreshbrand.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 0023-0240-04
    Refresh
    P.M.

    Lubricant Eye Ointment
     NIGHTTIME OINTMENT
    Net wt. 0.12 oz (3.5 g) Sterile

    PRINCIPAL DISPLAY PANEL
NDC 0023-0240-04
Refresh
P.M.
Nighttime Ointment
Net wt. 0.12 oz (3.5 g) Sterile

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  • INGREDIENTS AND APPEARANCE
    REFRESH P.M. 
    mineral oil, petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-0240
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    mineral oil (UNII: T5L8T28FGP) (mineral oil - UNII:T5L8T28FGP) mineral oil 425 mg  in 1 g
    petrolatum (UNII: 4T6H12BN9U) (petrolatum - UNII:4T6H12BN9U) petrolatum 573 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    lanolin alcohols (UNII: 884C3FA9HE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0023-0240-21 1 in 1 CARTON 04/23/1990
    1 3.5 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0023-0240-04 1 in 1 CARTON 04/23/1990
    2 3.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part349 04/23/1990
    Labeler - Allergan, Inc. (144796497)
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