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
  • 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 18, 2019

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

  • 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 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.

    • Keep carton for full drug facts.
  • Inactive Ingredients

    microcrystalline wax, stearic acid, wheat germ oil

  • Questions?

    call 1-800-344-7239

    Distributed by: INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

    CLINICALLY PROVEN SYMPTOMATIC RELIEF

    Temporarily relieves discomfort due to minor irritations including:

    • Burning
    • Stinging
    • Itching
  • PRINCIPAL DISPLAY PANEL

    Ophthalmologist
    Tested
    Stye
    Sterile Lubricant
    Eye Ointment
    NET WT. 0.125 OZ (3.5g)
    SAFETY SEALED CAP

    PRINCIPAL DISPLAY PANEL 
Ophthalmologist
Tested
Stye™
Sterile Lubricant
Eye Ointment
NET WT. 0.125 OZ (3.5g)
SAFETY SEALED CAP

  • 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 FINALpart34906/15/2010
    Labeler - Insight Pharmaceuticals LLC (055665422)