Label: LANOLIN, PETROLATUM ointment

  • Category: HUMAN OTC DRUG LABEL

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 August 10, 2021

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  • Active ingredients

    Lanolin 15.5%

    Petrolatum 53.4%

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor: cuts - scrapes - burns
    • temporarily protects and helps relieve chafed, chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    • do not get into eyes
  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • for skin protectant use: apply as needed
    • for diaper rash use:
    • change wet or soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • other information

    store between 20º and 25ºC (68º and 77º F)

  • Inactive ingredients

    cod liver oil (contains vitamins A+D), fragrance, light mineral oil, microcrystalline wax, paraffin

  • SPL UNCLASSIFIED SECTION

    Made in U.S.A. of U.S. and Foreign Parts

    Manufactured by Vi-Jon, Inc.

    St. Louis, MO 63114

    Questions or Comments?  1-888-593-0593

    www.mymountainfalls.com

    *This product is not manufactured or distributed by Shering-Plough Healthcare Products, Inc., distributor of A + D Original Ointment

  • principal display panel

    Mountain Falls Vitamin A&D diaper rash ointment

    skin protectant

    Compare to A+D

    NET WT 4 OZ (113 g)

    image description

  • INGREDIENTS AND APPEARANCE
    LANOLIN, PETROLATUM 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN133 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM459 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-013-261 in 1 CARTON10/03/2017
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/03/2017
    Labeler - Vi-Jon, LLC (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-013)