Label: EQUATE LUBRICANT STYE- mineral oil, white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL

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 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Equate

    Lubricant Stye Ointment

    49035-879-50

    Drug Facts

  • Active ingredients 

    Mineral Oil 31.9% and

    White Petrolatum 57.7%

  • Purpose

    Emollient

  • Uses

    • for the temporary relief of discomfort due to minor irritations.

  • Warnings

    • For use in the eye(s) only. 

    • Retain outer carton for full product drug facts.

    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.

    • the condition worsens for persists for more than 72 hours.

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

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

  • Directions

    • pull down the lower lid of the affected eye(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

  • Other Information

    • store at room temperature 15º -30ºC (59º-86ºF).

    • see crimp of tube or box for Lot Number and Expiration Date.

    •Do not use if bottom ridge of tube cap is exposed.

  • Inactive ingredients

    •Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

  • Questions or comments?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    NDC 49035-879-50
    Equate
    Sterile
    Lubricant
    Stye Ointment
    NET WT 0.125 OZ (3.5g)

    NDC 49035-879-50 Equate Sterile Lubricant Stye Ointment NET WT 0.125 OZ (3.5g)

  • INGREDIENTS AND APPEARANCE
    EQUATE LUBRICANT STYE 
    mineral oil, white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-879
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL319 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM577 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-879-501 in 1 CARTON05/12/2017
    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 FINALpart34905/12/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Altaire Pharmaceuticals, Inc. (786790378)
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