Label: EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE- mineral oil and 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 January 19, 2018

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  • SPL UNCLASSIFIED SECTION

    Equate

    Restore PM Nighttime Lubricant Eye Ointment

    49035-191-50

                           

    Drug Facts

  • Active ingredients

    Mineral Oil 42.5% and White Petrolatum 57.3%

  • Purpose

    Eye Lubricant

  • Uses

    • for the temporary relief of burning, irritation and discomfort due to dryness of the eye.

    • exposure to wind or sun

    • may be used as a protectant against further irritation.

  • Warnings

    • For use in the eyes only.  • Save box for complete information.

    When using this product 

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

    • replace cap after use.

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye.

    • condition worsens for persists for more than 72 hours.

    If pregnant or breast feeding,

    ask a health professional before use. 

    Keep this and all drugs out of the reach of children. 

    If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • 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, every 3-4 hours or as directed by doctor.

  • Other Information

    • Do not use if bottom ridge of tube cap is exposed, and if imprinted seals on side flaps are not intact and completely legible • store at room temperature 15º-30ºC (59º-86ºF) • store away from heat • keep from freezing • see crimp of tube or box for lot number and expiration date.

  • Inactive ingredients 

    lanolin alcohols

  • Questions or comments?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-191-50
    equate
    Restore PM
    NIGHTTIME LUBRICANT
    EYE OINTMENT
    Sterile
    NET WT 0.125 OZ (3.5g)

    NDC 49035-191-50 equate Restore PM NIGHTTIME LUBRICANT EYE OINTMENT Sterile NET WT 0.125 OZ (3.5g)

  • INGREDIENTS AND APPEARANCE
    EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE 
    mineral oil and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-191
    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:49035-191-501 in 1 BOX03/14/2013
    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 FINALpart34903/14/2013
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
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