Label: MAJOR LUBRIFRESH PM- mineral oil and white petrolatum ointment

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

Drug Label Information

Updated March 17, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients                                               Purpose

    Mineral oil 15%...................................................Lubricant

    White petrolatum 83%.........................................Lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
    • May be used as a protectant against further irritation
  • WARNINGS

    Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface
    • Keep tube tightly closed
  • ASK DOCTOR

    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 more 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 (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • Wash your hands.
    • Pull down the lower lid of the affected eye(s) 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.
  • STORAGE AND HANDLING

    Other information

    • Store away from heat
    • Protect from freezing
    • Use before expiration date marked on container
    • Store at 59°-86°F (15°-30°C)
  • INACTIVE INGREDIENT

    Inactive ingredients

    Lanolin alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Major Pharmaceuticals

    17177 N Laurel Park Dr.,

    Suiet 233

    Livonia, MI 48150

  • If pregnant or breast feeding

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

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    MAJOR LUBRIFRESH PM 
    mineral oil and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6488
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM830 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6488-381 in 1 CARTON09/11/2015
    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 DrugM01809/11/2015
    Labeler - Major Pharmaceuticals (191427277)