Label: STYE- mineral oil and petrolatum gel

  • NDC Code(s): 63736-238-24
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • SPL UNCLASSIFIED SECTION

    STYE- mineral oil and petrolatum gel
    ------

    Stye™
    Sterile Lubricant

    Eye Ointment

    Drug Facts

  • Active ingredients

    Mineral oil 31.9%

  • Purpose

    Emollient

  • Active ingredients

    White petrolatum 57.7%

  • Purpose

    Emollient

  • Uses

    • temporarily relieves burning and irritation of the eye
    • as a lubricant to prevent further irritation of the eye
  • Warnings

    For external use only.

    When using this product

    • to 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
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

    Do not use if cap neck-seal is cut, broken, or missing.

  • Inactive Ingredients

    microcrystalline wax, stearic acid, wheat germ oil

  • Questions?

    1-800-344-7239

  • PRINCIPAL DISPLAY PANEL


    Stye
    Sterile Lubricant
    Eye Ointment
    NET WT. 0.125 OZ (3.5g)

    PRINCIPAL DISPLAY PANEL 

Stye™
Sterile Lubricant
Eye Ointment
NET WT. 0.125 OZ (3.5g)

  • INGREDIENTS AND APPEARANCE
    STYE 
    mineral oil and petrolatum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-238
    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
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-238-2424 in 1 CASE06/15/2010
    11 in 1 BOX
    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 DrugM01806/15/2010
    Labeler - Insight Pharmaceuticals LLC (055665422)