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

  • NDC Code(s): 71406-125-35
  • Packager: AACE PHARMACEUTICALS, 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 October 26, 2022

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

  • SPL UNCLASSIFIED SECTION

    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.

  • 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

    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 or 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the 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(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.
  • OTHER INFORMATION

    • store at room temperature 15°-30°C (59°-86°F).

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

    • Use only if tape seals on top and bottom flaps are intact.

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

    Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

  • PRINCIPAL DISPLAY PANEL

    NDC#: 71406-125-35

    Compare to Stye TM Active ingredients*

    Lubricant Stye Ointment

    Temporarily relieves discomfort due to itching, burning, stinging & other minor irritations

    Not a cure for infection

    Preservative-free

    Net Wt. 0.125 oz (3.5 g) Sterile

    Distributed By:

    AACE Pharmaceuticals, Inc., Fairfield, NJ 07004

    www. aacepharma.com

    Rev. 00

    This product is not manufactured or distributed by Insight Pharmaceutical Corp., owner of the registered trademark Stye TM

    Stye Ointment

  • INGREDIENTS AND APPEARANCE
    LUBRICANT STYE 
    mineral oil, white petrolatum ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71406-125
    Route of AdministrationOPHTHALMIC
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71406-125-351 in 1 CARTON03/19/2020
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/19/2020
    Labeler - AACE PHARMACEUTICALS, INC. (080630748)