MAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]

MAJOR LUBRIFRESH PM (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [MAJOR PHARMACEUTICALS]
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NDC 0904-6488-38
Set ID bd85d4b6-7093-4e89-ae7b-2a293a0775f2
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART349
  • 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

    When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using
  • 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 right away.

  • INDICATIONS & USAGE

    Directions

    • pull down the lower lid of the affected eye(s) and apply a small amount (1/4") of ointment to the inside of eyelid
  • 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

  • PRINCIPAL DISPLAY PANEL

    Carton

    Tube

  • 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 CARTON09/11/201511/30/2020
    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 finalpart34909/11/201511/30/2020
    Labeler - Major Pharmaceuticals (191427277)