Label: MINERAL OIL WITH PETROLEUM- mineral oil and white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 9, 2024

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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredientsPurpose
    Mineral Oil 3%Lubricant
    White Petrolatum 94%Lubricant
  • Uses

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

    For use in eyes only. Retain outer carton for full product drug facts.

    Do not use if: • you are sensitive to any ingredient in this product.

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

  • Stop use

    Stop use and ask a doctor if you are experiencing any of the following:

    • You experience eye pain or change in vision, continued dryness or irritation of the eye. • The condition worsens. • Symptoms last longer than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

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

  • Other information

    • • Do not use if bottom ridge of tube cap is exposed. Store at room temperature 15° to 30° C (59° to 86°F) • Keep tube tightly closed. • See crimp of tube or box for lot number and expiration date.
  • Inactive ingredient

    Lanolin alcohol.

  • QUESTIONS

    Questions or Comments? • 888-969-6855

  • PRINCIPAL DISPLAY PANEL

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    MINERAL OIL WITH PETROLEUM 
    mineral oil and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1383
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL30 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM940 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1383-911 in 1 CARTON02/27/2023
    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 DrugM01802/27/2023
    Labeler - Rugby Laboratories (079246066)