Label: MINERAL oil

  • NDC Code(s): 64120-106-11
  • Packager: DOMINION VETERINARY LABORATORIES LTD.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 19, 2021

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  • INDICATIONS:

    MINERAL OIL IS RECOMMENDED AS AN INTESTINAL LUBRICANT TO RELIEVE CONSTIPATION, A DRY SKIN SOFTENER, AND AS A COAT DRESSING.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Mineral Oil_4-L

  • INGREDIENTS AND APPEARANCE
    MINERAL 
    mineral oil
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:64120-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64120-106-114000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/10/2021
    Labeler - DOMINION VETERINARY LABORATORIES LTD. (200081883)
    Establishment
    NameAddressID/FEIBusiness Operations
    DOMINION VETERINARY LABORATORIES LTD.200081883manufacture, api manufacture