Label: HUMCO MINERAL OIL LIGHT- mineral oil liquid

  • NDC Code(s): 0395-1673-28
  • Packager: Humco Holding Group, Inc.
  • 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 March 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Mineral Oil

  • Purpose

    Skin Protectant

  • Use

    Help treat and prevent diaper rash. Protects chafed skin due to diaper rash and, helps seal out wetness.

  • Warnings

    For external use only. For internal use we suggest Humco Mineral Oil Heavy USP.

    Avoid contact with eyes. In case of eye contact, flush eyes with running water for 15 minutes.

  • When using this product

    Discontinue use if diaper rash worsens or does not improve and contact doctor.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Change wet or soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply mineral oil liberally as often as necessary, with each diapper change, especially at bed time or when exposure to wet diapers may be prolonged.

  • Inactive ingredient

    dl-alpha tocopherol as a preservative.

  • Other information

    Keep tightly closed and protect from direct sunlight.

  • Principal display panel

    MinLT.jpgMinLight.jpglabel

    image description

  • INGREDIENTS AND APPEARANCE
    HUMCO MINERAL OIL LIGHT 
    mineral oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-1673
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL1000 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-1673-283800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/1998
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-1673) , analysis(0395-1673) , pack(0395-1673) , label(0395-1673)
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