Label: STYE EYE- mineral oil, white petrolatum ointment 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 December 20, 2022

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

View All Sections
  • ACTIVE INGREDIENTS

    Mineral Oil 31.9%

    White Petrolatum 57.7%

  • PURPOSE

    Mineral oil.........Eye lubricant

    White petrolatum.....Eye lubricant

  • USES

    • For temporary relief of irritation or dryness in the eye.

    • May be used as a protectant against further irritation.

  • WARNINGS

    • For use in eyes only.
    • Retain outer carton for full product drug facts.
    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface.
    • Keep tube tightly closed.

    If pregnant or breast feeding

    • If pregnant or breast feeding, ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.

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

    Stop use and ask a doctor if

    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.

  • DIRECTIONS

    • Wash your hands.

    • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.

  • OTHER INFORMATION

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

    • See crimp of tube or box for lot number and expiration date.

    • Store away from heat. • Protect from freezing. • Use before expiration date on the tube.

    • Store at 59°-86° F (15°- 30°C)

  • INACTIVE INGREDIENTS

    Microcrystalline Wax, Stearic Acid, Wheat Germ Oil.

  • Questions or comments?

    Questions or comments?

    1-888-969-6855

    8am to4 pm; Monday - Friday.

  • PRINCIPAL DISPLAY PANEL

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    STYE EYE 
    mineral oil, white petrolatum ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-405
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-405-321 in 1 CARTON12/19/2022
    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 finalpart34912/19/2022
    Labeler - TRP Company (105185719)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!