Label: MINERAL OIL WITH PETROLEUM- mineral oil and white petrolatum 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 February 27, 2023

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  • 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 finalpart34902/27/2023
    Labeler - Rugby Laboratories (079246066)
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